Trial Outcomes & Findings for Refractory Chronic Cough Improvement Via NAL ER (RIVER) (NCT NCT05962151)
NCT ID: NCT05962151
Last Updated: 2026-03-30
Results Overview
Relative change in 24-hour (combined daytime and nighttime) cough frequency (coughs per hour) from baseline was assessed. Assessment was done using objective digital cough monitoring. Baseline was defined as the last non-missing assessment, prior to the first dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Baseline, Day 21
Results posted on
2026-03-30
Participant Flow
Participants were enrolled at 14 sites from 30 November 2023 to 06 January 2025.
A total of 142 participants were screened, of which 66 participants were enrolled and randomized to receive treatment in this study.
Participant milestones
| Measure |
First NAL ER Then Placebo
Participants received NAL ER in Treatment Period 1 with dose titration from 27 milligrams (mg) once daily (QD) to 108 mg twice daily (BID). Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period. Treatment Period 1 was followed by a 21-day washout period, after which participants received placebo in Treatment Period 2.
|
First Placebo Then NAL ER
Participants received placebo in Treatment Period 1. Treatment Period 1 was followed by a 21-day washout period, after which participants received NAL ER in Treatment Period 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
|---|---|---|
|
Treatment Period 1 (21 Days)
STARTED
|
34
|
32
|
|
Treatment Period 1 (21 Days)
Full Analysis Set (FAS)
|
30
|
29
|
|
Treatment Period 1 (21 Days)
COMPLETED
|
28
|
29
|
|
Treatment Period 1 (21 Days)
NOT COMPLETED
|
6
|
3
|
|
Washout Period (21 Days)
STARTED
|
28
|
29
|
|
Washout Period (21 Days)
COMPLETED
|
28
|
29
|
|
Washout Period (21 Days)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (21 Days)
STARTED
|
28
|
29
|
|
Treatment Period 2 (21 Days)
COMPLETED
|
27
|
24
|
|
Treatment Period 2 (21 Days)
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
First NAL ER Then Placebo
Participants received NAL ER in Treatment Period 1 with dose titration from 27 milligrams (mg) once daily (QD) to 108 mg twice daily (BID). Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period. Treatment Period 1 was followed by a 21-day washout period, after which participants received placebo in Treatment Period 2.
|
First Placebo Then NAL ER
Participants received placebo in Treatment Period 1. Treatment Period 1 was followed by a 21-day washout period, after which participants received NAL ER in Treatment Period 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
|---|---|---|
|
Treatment Period 1 (21 Days)
Adverse Event
|
5
|
1
|
|
Treatment Period 1 (21 Days)
Withdrawal by Subject
|
1
|
2
|
|
Treatment Period 2 (21 Days)
Adverse Event
|
0
|
4
|
|
Treatment Period 2 (21 Days)
Withdrawal by Subject
|
1
|
0
|
|
Treatment Period 2 (21 Days)
Reason not specified
|
0
|
1
|
Baseline Characteristics
The FAS population consisted of all participants who received at least one dose of study drug, and for whom there was a non-missing Baseline and Day 21 primary endpoint measurement in at least one treatment period.
Baseline characteristics by cohort
| Measure |
First NAL ER Then Placebo
n=34 Participants
Participants received NAL ER in Treatment Period 1 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period. Treatment Period 1 was followed by a 21-day washout period, after which participants received placebo in Treatment Period 2.
|
First Placebo Then NAL ER
n=32 Participants
Participants received placebo in Treatment Period 1. Treatment Period 1 was followed by a 21-day washout period, after which participants received NAL ER in Treatment Period 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 9.16 • n=34 Participants
|
57.2 years
STANDARD_DEVIATION 11.08 • n=32 Participants
|
60.2 years
STANDARD_DEVIATION 10.47 • n=66 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=34 Participants
|
21 Participants
n=32 Participants
|
44 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=34 Participants
|
11 Participants
n=32 Participants
|
22 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=34 Participants
|
32 Participants
n=32 Participants
|
66 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=34 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=34 Participants
|
1 Participants
n=32 Participants
|
4 Participants
n=66 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=34 Participants
|
30 Participants
n=32 Participants
|
61 Participants
n=66 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=66 Participants
|
|
24-hour Cough Frequency
|
45.869 coughs per hour
STANDARD_DEVIATION 54.7593 • n=30 Participants • The FAS population consisted of all participants who received at least one dose of study drug, and for whom there was a non-missing Baseline and Day 21 primary endpoint measurement in at least one treatment period.
|
26.374 coughs per hour
STANDARD_DEVIATION 24.8968 • n=29 Participants • The FAS population consisted of all participants who received at least one dose of study drug, and for whom there was a non-missing Baseline and Day 21 primary endpoint measurement in at least one treatment period.
|
36.287 coughs per hour
STANDARD_DEVIATION 43.5333 • n=59 Participants • The FAS population consisted of all participants who received at least one dose of study drug, and for whom there was a non-missing Baseline and Day 21 primary endpoint measurement in at least one treatment period.
|
PRIMARY outcome
Timeframe: Baseline, Day 21Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received (NAL ER or placebo), regardless of period. Participants who received both treatments were counted in both the NAL ER and placebo arms. Overall number analyzed is the number of participants available for outcome measure analysis.
Relative change in 24-hour (combined daytime and nighttime) cough frequency (coughs per hour) from baseline was assessed. Assessment was done using objective digital cough monitoring. Baseline was defined as the last non-missing assessment, prior to the first dose of study drug.
Outcome measures
| Measure |
NAL ER
n=54 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=53 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Relative Change From Baseline in 24-hour Cough Frequency at Day 21
|
-64.92 coughs per hour
Standard Deviation 36.552
|
-9.36 coughs per hour
Standard Deviation 40.952
|
SECONDARY outcome
Timeframe: Up to Week 15Population: The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data were summarized by actual treatment received (NAL ER or placebo), regardless of period. Participants who received both treatments were counted in both the NAL ER and placebo arms.
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE was defined as any AE that occurs after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.
Outcome measures
| Measure |
NAL ER
n=63 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=59 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs)
|
50 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Up to Week 15Population: The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data were summarized by actual treatment received (NAL ER or placebo), regardless of period. Participants who received both treatments were counted in both the NAL ER and placebo arms.
The clinical laboratory parameters included urinalysis, hematology, serum chemistry and coagulation. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
NAL ER
n=63 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=59 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments
Coagulation
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments
Urinalysis
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments
Hematology
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments
Serum Chemistry
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 15Population: The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data were summarized by actual treatment received (NAL ER or placebo), regardless of period. Participants who received both treatments were counted in both the NAL ER and placebo arms. Overall number analyzed is the number of participants available for outcome measure analysis.
Vital signs measurements included blood pressure, heart rate, respiration rate, body temperature, pulse oximetry, and weight. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
NAL ER
n=63 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=59 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Blood Pressure
|
11 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Heart Rate
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Respiration Rate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Body Temperature
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Pulse Oximetry
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Weight
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 15Population: The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data were summarized by actual treatment received (NAL ER or placebo), regardless of period. Participants who received both treatments were counted in both the NAL ER and placebo arms.
Changes in ECG data such as heart rate, rhythm, and other clinically significant abnormalities (left ventricular hypertrophy, pathological Q-waves) were measured. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
NAL ER
n=63 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=59 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 15Population: The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data were summarized by actual treatment received (NAL ER or placebo), regardless of period. Participants who received both treatments were counted in both the NAL ER and placebo arms.
Physical examination included examination of the following body systems: general appearance, eyes, ears, nose, throat, head and neck, chest and lungs, cardiovascular, abdomen, musculoskeletal, lymphatic, dermatological, neurological, and extremities. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
NAL ER
n=63 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=59 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Physical Examination Parameters
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline, Days 7 and 14Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received, regardless of period. Those who received both treatments were counted in both arms. 'Overall number analyzed'= participants available for analysis. 'Number analyzed'= participants with data available for analysis at specified time-point.
Relative change in 24-hour (combined daytime and nighttime) cough frequency (coughs per hour) from baseline was assessed. Assessment was done using objective digital cough monitoring. Baseline was defined as the last non-missing assessment, prior to the first dose of study drug.
Outcome measures
| Measure |
NAL ER
n=57 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=55 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Relative Change From Baseline in 24-hour Cough Frequency at Days 7 and 14
Change at Day 7
|
-56.12 coughs per hour
Standard Deviation 30.733
|
7.70 coughs per hour
Standard Deviation 39.929
|
|
Relative Change From Baseline in 24-hour Cough Frequency at Days 7 and 14
Change at Day 14
|
-59.20 coughs per hour
Standard Deviation 33.304
|
-5.14 coughs per hour
Standard Deviation 40.457
|
SECONDARY outcome
Timeframe: Days 7, 14, and 21Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received, regardless of period. Those who received both treatments were counted in both arms. 'Overall number analyzed'= participants available for analysis. 'Number analyzed'= participants with data available for analysis at specified time-point.
Responders were defined as those with ≥30%, ≥50%, or ≥75% reduction in 24-hour cough frequency from Baseline at Days 7, 14, or 21.
Outcome measures
| Measure |
NAL ER
n=57 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=55 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Percentage of Responders With >=30%, 50% and 75% Reduction in 24-hour Cough Frequency
>=75% Reduction at Day 21
|
53.7 percentage of participants
Interval 39.6 to 67.4
|
1.9 percentage of participants
Interval 0.0 to 10.1
|
|
Percentage of Responders With >=30%, 50% and 75% Reduction in 24-hour Cough Frequency
>=50% Reduction at Day 21
|
79.6 percentage of participants
Interval 66.5 to 89.4
|
15.1 percentage of participants
Interval 6.7 to 27.6
|
|
Percentage of Responders With >=30%, 50% and 75% Reduction in 24-hour Cough Frequency
>=30% Reduction at Day 7
|
78.9 percentage of participants
Interval 66.1 to 88.6
|
14.5 percentage of participants
Interval 6.5 to 26.7
|
|
Percentage of Responders With >=30%, 50% and 75% Reduction in 24-hour Cough Frequency
>=30% Reduction at Day 14
|
76.4 percentage of participants
Interval 63.0 to 86.8
|
24.1 percentage of participants
Interval 13.5 to 37.6
|
|
Percentage of Responders With >=30%, 50% and 75% Reduction in 24-hour Cough Frequency
>=30% Reduction at Day 21
|
87.0 percentage of participants
Interval 75.1 to 94.6
|
30.2 percentage of participants
Interval 18.3 to 44.3
|
|
Percentage of Responders With >=30%, 50% and 75% Reduction in 24-hour Cough Frequency
>=50% Reduction at Day 7
|
63.2 percentage of participants
Interval 49.3 to 75.6
|
3.6 percentage of participants
Interval 0.4 to 12.5
|
|
Percentage of Responders With >=30%, 50% and 75% Reduction in 24-hour Cough Frequency
>=50% Reduction at Day 14
|
67.3 percentage of participants
Interval 53.3 to 79.3
|
11.1 percentage of participants
Interval 4.2 to 22.6
|
|
Percentage of Responders With >=30%, 50% and 75% Reduction in 24-hour Cough Frequency
>=75% Reduction at Day 7
|
38.6 percentage of participants
Interval 26.0 to 52.4
|
0.0 percentage of participants
Interval 0.0 to 6.5
|
|
Percentage of Responders With >=30%, 50% and 75% Reduction in 24-hour Cough Frequency
>=75% Reduction at Day 14
|
41.8 percentage of participants
Interval 28.7 to 55.9
|
1.9 percentage of participants
Interval 0.0 to 9.9
|
SECONDARY outcome
Timeframe: Baseline, Days 7, 14, and 21Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received, regardless of period. Those who received both treatments were counted in both arms. 'Overall number analyzed'= participants available for analysis. 'Number analyzed'= participants with data available for analysis at specified time-point.
Awake cough was defined as cough that occurs between the time that the participant is awaken 24 hours after the digital cough monitor was applied for use. Assessment was done using objective digital cough monitoring. Baseline was defined as the last non-missing assessment, prior to the first dose of study drug.
Outcome measures
| Measure |
NAL ER
n=57 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=55 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Relative Change From Baseline in Awake Cough Frequency at Days 7, 14, and 21
Change at Day 7
|
-54.17 coughs per hour
Standard Deviation 31.996
|
5.25 coughs per hour
Standard Deviation 37.779
|
|
Relative Change From Baseline in Awake Cough Frequency at Days 7, 14, and 21
Change at Day 14
|
-59.29 coughs per hour
Standard Deviation 32.437
|
-5.01 coughs per hour
Standard Deviation 37.037
|
|
Relative Change From Baseline in Awake Cough Frequency at Days 7, 14, and 21
Change at Day 21
|
-64.96 coughs per hour
Standard Deviation 34.332
|
-9.37 coughs per hour
Standard Deviation 39.322
|
SECONDARY outcome
Timeframe: Baseline, Days 7, 14 and 21Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received, regardless of period. Those who received both treatments were counted in both arms. 'Overall number analyzed'= participants available for analysis. 'Number analyzed'= participants with data available for analysis at specified time-point.
Sleep cough frequency was intended as the average coughs per hour while the participant was flagged as being asleep. Assessment was done using objective digital cough monitoring. Percent change in cough frequency (coughs per hour) from baseline was assessed. Baseline was defined as the last non-missing assessment, prior to the first dose of study drug.
Outcome measures
| Measure |
NAL ER
n=48 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=45 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Relative Change From Baseline in Sleep Cough Frequency at Days 7, 14, and 21
Change at Day 7
|
-32.86 coughs per hour
Standard Deviation 198.036
|
53.24 coughs per hour
Standard Deviation 252.834
|
|
Relative Change From Baseline in Sleep Cough Frequency at Days 7, 14, and 21
Change at Day 14
|
-7.11 coughs per hour
Standard Deviation 341.280
|
18.55 coughs per hour
Standard Deviation 165.295
|
|
Relative Change From Baseline in Sleep Cough Frequency at Days 7, 14, and 21
Change at Day 21
|
-15.70 coughs per hour
Standard Deviation 244.516
|
30.11 coughs per hour
Standard Deviation 207.430
|
SECONDARY outcome
Timeframe: Baseline, Days 7, 14, and 21Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received, regardless of period. Those who received both treatments were counted in both arms. 'Overall number analyzed'= participants available for analysis. 'Number analyzed'= participants with data available for analysis at specified time-point.
The CS-VAS is a brief, easily administered patient reported outcome (PRO) questionnaire that is used to assess cough severity in both acute and chronic cough. CS-VAS is a 1-item scale that rates the severity of participants' cough from 0 millimeter (mm) where 0 indicated "no cough" and 100 represented "worst cough ever". A negative change from baseline indicates improvement.
Outcome measures
| Measure |
NAL ER
n=56 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=55 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Change From Baseline in Cough Severity Visual Analogue Scale (CS-VAS) at Days 7, 14, and 21
Change at Day 7
|
-22.2 millimeter
Standard Deviation 22.79
|
-2.9 millimeter
Standard Deviation 13.82
|
|
Change From Baseline in Cough Severity Visual Analogue Scale (CS-VAS) at Days 7, 14, and 21
Change at Day 14
|
-29.7 millimeter
Standard Deviation 22.72
|
-4.1 millimeter
Standard Deviation 15.34
|
|
Change From Baseline in Cough Severity Visual Analogue Scale (CS-VAS) at Days 7, 14, and 21
Change at Day 21
|
-29.9 millimeter
Standard Deviation 23.75
|
-5.3 millimeter
Standard Deviation 15.96
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received, regardless of period. Those who received both treatments were counted in both arms. Overall number analyzed is the number of participants available for outcome measure analysis.
LCQ is a self-reporting quality of life measure of chronic cough. It consists of 19 items with a 7-point Likert response scale ranging from 1 to 7. The responses are as follows: 1 = all of the time, 2 = most of the time, 3 = a good bit of the time, 4 = some of the time, 5 = a little of the time, 6 = hardly any of the time, and 7 = none of the time. Each item is designed to assess cough symptoms and the impact of cough across three main domains, physical (8 items), psychological (7 items), and social (4 items). Domain scores are calculated as the total score from items in the domain divided by the number of items in the domain and range from 1 to 7. The LCQ total score is calculated by summing the individual domain scores and ranges from 3 to 21, with higher scores indicating better health status.
Outcome measures
| Measure |
NAL ER
n=56 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=55 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Day 21
|
4.50 score on a scale
Standard Deviation 3.818
|
0.25 score on a scale
Standard Deviation 2.476
|
SECONDARY outcome
Timeframe: Baseline, Days 7, 14, and 21Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received, regardless of period. Those who received both treatments were counted in both arms. 'Overall number analyzed'= participants available for analysis. 'Number analyzed'= participants with data available for analysis at specified time-point.
Patient-Reported Cough Frequency (PR-CF) is a daily, self-reported, 1 item scale, PRO that is used to assess cough frequency. Participants rate their cough frequency over the past 24 hours using a 5-point Likert scale (0- to 4: 0 = Not at all, 1 = Rarely, 2 = Occasionally, 3 = Frequently, 4 = Almost constantly). A higher score indicates more severe symptoms. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
NAL ER
n=53 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=50 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Change From Baseline in Patient-Reported Cough Frequency (PR-CF) at Days 7, 14, and 21
Change at Day 7
|
-0.74 score on a scale
Standard Deviation 0.812
|
0.02 score on a scale
Standard Deviation 0.685
|
|
Change From Baseline in Patient-Reported Cough Frequency (PR-CF) at Days 7, 14, and 21
Change at Day 14
|
-0.92 score on a scale
Standard Deviation 0.763
|
-0.13 score on a scale
Standard Deviation 0.703
|
|
Change From Baseline in Patient-Reported Cough Frequency (PR-CF) at Days 7, 14, and 21
Change at Day 21
|
-1.08 score on a scale
Standard Deviation 0.805
|
-0.27 score on a scale
Standard Deviation 0.811
|
SECONDARY outcome
Timeframe: Days 7, 14, and 21Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received, regardless of period. Those who received both treatments were counted in both arms. 'Overall number analyzed'= participants available for analysis. 'Number analyzed'= participants with data available for analysis at specified time-point.
PR-CF is a daily, self-reported, 1 item scale, PRO that is used to assess cough frequency. Participants rate their cough frequency over the past 24 hours using a 5-point Likert scale (0 to 4: 0 = Not at all, 1 = Rarely, 2 = Occasionally, 3 = Frequently, 4 = Almost constantly). A higher score indicates more severe symptoms. PR CF responders were defined as participants with at least a one category improvement at Days 7, 14, and 21.
Outcome measures
| Measure |
NAL ER
n=53 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=50 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Percentage of PR-CF Responders With at Least One Category Improvement at Days 7, 14, and 21
Day 7
|
62.3 percentage of participants
Interval 47.9 to 75.2
|
18.0 percentage of participants
Interval 8.6 to 31.4
|
|
Percentage of PR-CF Responders With at Least One Category Improvement at Days 7, 14, and 21
Day 14
|
69.2 percentage of participants
Interval 54.9 to 81.3
|
27.1 percentage of participants
Interval 15.3 to 41.8
|
|
Percentage of PR-CF Responders With at Least One Category Improvement at Days 7, 14, and 21
Day 21
|
75.5 percentage of participants
Interval 61.7 to 86.2
|
34.7 percentage of participants
Interval 21.7 to 49.6
|
SECONDARY outcome
Timeframe: Baseline, Days 7, 14 and 21Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received, regardless of period. Those who received both treatments were counted in both arms. 'Overall number analyzed'= participants available for analysis. 'Number analyzed'= participants with data available for analysis at specified time-point.
The PGI-S Cough scale is a self-reported, single-item categorical scale that is increasingly used when assessing chronic cough. Participants rate the severity of their cough in the last week with a 4-point Likert scale ranging from 0 to 3 (0 = No Cough, 1 = Mild, 2 = Moderate, or 3 = Severe). A higher score indicates more severe symptoms. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
NAL ER
n=56 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=55 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) Cough at Days 7, 14, and 21
Change at Day 7
|
-0.45 score on a scale
Standard Deviation 0.601
|
0.06 score on a scale
Standard Deviation 0.627
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) Cough at Days 7, 14, and 21
Change at Day 14
|
-0.84 score on a scale
Standard Deviation 0.757
|
-0.09 score on a scale
Standard Deviation 0.564
|
|
Change From Baseline in Patient Global Impression of Severity (PGI-S) Cough at Days 7, 14, and 21
Change at Day 21
|
-0.98 score on a scale
Standard Deviation 0.751
|
-0.09 score on a scale
Standard Deviation 0.646
|
SECONDARY outcome
Timeframe: Days 7, 14, and 21Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received, regardless of period. Those who received both treatments were counted in both arms. 'Overall number analyzed'= participants available for analysis. 'Number analyzed'= participants with data available for analysis at specified time-point.
The PGI-C Cough scale is a self-reported, single-item categorical scale that is increasingly used when assessing chronic cough. Participants rate the severity of their cough in the last week with a 7-point Likert scale ranging from 0 to 7 (0 = No Cough, 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, or 7 = Much worse). A higher score indicates more severe symptoms. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
NAL ER
n=56 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=55 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Patient Global Impression of Change for Cough (PGI-C) Score at Days 7, 14, and 21
Day 7
|
2.64 score on a scale
Standard Deviation 1.103
|
4.04 score on a scale
Standard Deviation 1.213
|
|
Patient Global Impression of Change for Cough (PGI-C) Score at Days 7, 14, and 21
Day 14
|
2.41 score on a scale
Standard Deviation 1.332
|
3.91 score on a scale
Standard Deviation 1.229
|
|
Patient Global Impression of Change for Cough (PGI-C) Score at Days 7, 14, and 21
Day 21
|
2.07 score on a scale
Standard Deviation 1.189
|
3.71 score on a scale
Standard Deviation 1.066
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received, regardless of period. Those who received both treatments were counted in both arms. Overall number analyzed is the number of participants available for outcome measure analysis.
The CGI-S Cough scale is an investigator-reported, single-item categorical scale that is increasingly used when assessing the severity of the condition. Investigator rate the severity of their cough in the last week with a 4-point Likert scale ranging from 0 to 3 (0 = No Cough, 1 = Mild, 2 = Moderate, or 3 = Severe). A higher score indicates more severe symptoms. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
NAL ER
n=56 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=56 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Change From Baseline in Clinicians Global Impression of Cough Severity Score (CGI-S) at Day 21
|
-1.02 score on a scale
Standard Deviation 0.700
|
-0.36 score on a scale
Standard Deviation 0.672
|
SECONDARY outcome
Timeframe: Day 21Population: The FAS population consisted of all participants who received at least one dose of study drug and had non-missing Baseline and Day 21 primary endpoint data in at least one treatment period. Data were summarized by actual treatment received, regardless of period. Those who received both treatments were counted in both arms. Overall number analyzed is the number of participants available for outcome measure analysis.
The PGI-C Cough scale is an investigator-reported, single-item categorical scale that is increasingly used when assessing the investigator's belief of the participant's overall improvement pre-treatment baseline. Investigator rate the change in improvement in the last week with a 7-point Likert scale ranging from 1 to 7 (1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6= Much worse, or 7= Very much worse). A higher score indicates more severe symptoms. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
NAL ER
n=56 Participants
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=56 Participants
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Clinicians Global Impression of Change for Cough Score (CGI-C) at Day 21
|
2.23 score on a scale
Standard Deviation 0.934
|
3.50 score on a scale
Standard Deviation 0.874
|
Adverse Events
NAL ER
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NAL ER
n=63 participants at risk
Participants received NAL ER in Treatment Period 1 or 2 with dose titration from 27 mg QD to 108 mg BID. Dosing was initiated at 27 mg QD, increased to 27 mg BID, then escalated to 54 mg BID and subsequently to 108 mg BID over the treatment period.
|
Placebo
n=59 participants at risk
Participants received placebo for 3 weeks through Treatment Period 1 or 2 of the study.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
28.6%
18/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
6.8%
4/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Nausea
|
22.2%
14/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
3.4%
2/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
6/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
3/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
5.1%
3/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Dry mouth
|
7.9%
5/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
5.1%
3/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Nervous system disorders
Somnolence
|
25.4%
16/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Nervous system disorders
Headache
|
15.9%
10/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
11.9%
7/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Nervous system disorders
Dizziness
|
19.0%
12/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
3.4%
2/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
General disorders
Fatigue
|
14.3%
9/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
5.1%
3/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Infections and infestations
Nasopharyngitis
|
6.3%
4/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
3.4%
2/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
2/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
5.1%
3/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
2/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
3.4%
2/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Defaecation urgency
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Faecaloma
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Lip swelling
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Nervous system disorders
Lethargy
|
3.2%
2/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Nervous system disorders
Tremor
|
4.8%
3/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Nervous system disorders
Disturbance in attention
|
3.2%
2/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Nervous system disorders
Hypoaesthesia
|
3.2%
2/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Nervous system disorders
Hyposmia
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Nervous system disorders
Neuralgia
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Nervous system disorders
Restless arm syndrome
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Nervous system disorders
Restless legs syndrome
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
General disorders
Drug withdrawal syndrome
|
3.2%
2/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
General disorders
Chills
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
General disorders
Feeling abnormal
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
General disorders
Feeling hot
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
General disorders
Feeling of relaxation
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
General disorders
Oedema peripheral
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
General disorders
Thirst
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
General disorders
Vessel puncture site pain
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Infections and infestations
Lower respiratory tract infection
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Infections and infestations
Nail infection
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Infections and infestations
Oral herpes
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Infections and infestations
Rhinitis
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Infections and infestations
Viral infection
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
3.4%
2/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
3/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.2%
2/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.2%
2/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
3.4%
2/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
2/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Injury, poisoning and procedural complications
Contusion
|
3.2%
2/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Injury, poisoning and procedural complications
Ear injury
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Injury, poisoning and procedural complications
Product administration error
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
3.4%
2/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Psychiatric disorders
Insomnia
|
4.8%
3/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Psychiatric disorders
Agitation
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Psychiatric disorders
Libido decreased
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Psychiatric disorders
Poor quality sleep
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Eye disorders
Vision blurred
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Eye disorders
Blepharitis
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Eye disorders
Ectropion
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Eye disorders
Eye pruritus
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Investigations
Blood alkaline phosphatase increased
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Investigations
Brain natriuretic peptide increased
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Investigations
International normalised ratio increased
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Investigations
Protein urine
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Ear and labyrinth disorders
Ear pruritus
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Ear and labyrinth disorders
Motion sickness
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Ear and labyrinth disorders
Tinnitus
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Renal and urinary disorders
Chromaturia
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Renal and urinary disorders
Glycosuria
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Cardiac disorders
Heart failure with preserved ejection fraction
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Vascular disorders
Hypertension
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
1.7%
1/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Blood and lymphatic system disorders
Neutrophilia
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
|
Immune system disorders
Allergy to arthropod bite
|
1.6%
1/63 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
0.00%
0/59 • Up to Week 15
The Safety Population consisted of all participants who had received at least one dose of NAL ER or Placebo. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).
|
Additional Information
James Cassella, Ph.D, Chief Development Officer
Trevi Therapeutics, Inc.
Phone: 203-304-2499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place