Trial Outcomes & Findings for Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal (NCT NCT01863186)
NCT ID: NCT01863186
Last Updated: 2022-03-22
Results Overview
The SOWS-Gossop was completed by the mITT population subject at baseline, once daily at 3.5 hours after the first dose of the study medication on Days 1 to 7. It consists of 10 items that are scored on a 4-point scale; 0=none, 1=mild, 2=moderate, and 3=severe. The overall score is the simple sum of the 10-item scores (minimum overall score of 0, maximum score of 30). Higher individual scores on the scale indicate greater symptom severity. However, as the outcome measure is a difference from placebo, a lower number indicates a better outcome. mITT population: all randomized subjects who received at least 1 dose of study medication
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
603 participants
Primary outcome timeframe
Days 1 through 7
Results posted on
2022-03-22
Participant Flow
Participant milestones
| Measure |
DB: Lofexidine HCl 2.4mg Dose
Participants were randomized to receive 2.4 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 2.4 mg (one tablet in each dose will be a placebo tablet to maintain the blind) for up to 7 days.
|
DB: Lofexidine HCl 3.2mg Dose
Participants were randomized to receive 3.2 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 3.2 mg for up to 7 days.
|
DB: Placebo
Participants were randomized to receive placebo during the double-blind period of the study. Subjects will take 4 tablets QID for up to 7 days.
Placebo: Lofexidine-matching tablets without the active pharmaceutical ingredient will be provided as 4 tablets QID during the double-blind portion of the study to subjects randomized to placebo.
|
OL: All Lofexidine HCl
Participants were given the option to receive lofexidine HCl tablets for up to 7 additional days, following the double blind period. Dosing regimens are at the discretion of the Investigator, but total daily dose will not exceed 3.2 mg.
|
|---|---|---|---|---|
|
Double-blind Phase
STARTED
|
229
|
222
|
151
|
0
|
|
Double-blind Phase
COMPLETED
|
95
|
88
|
42
|
0
|
|
Double-blind Phase
NOT COMPLETED
|
134
|
134
|
109
|
0
|
|
Open-label Phase
STARTED
|
0
|
0
|
0
|
83
|
|
Open-label Phase
COMPLETED
|
0
|
0
|
0
|
70
|
|
Open-label Phase
NOT COMPLETED
|
0
|
0
|
0
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
Baseline characteristics by cohort
| Measure |
DB: Lofexidine HCl 2.4mg Dose
n=229 Participants
Participants were randomized to receive 2.4 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 2.4 mg (one tablet in each dose will be a placebo tablet to maintain the blind) for up to 7 days.
|
DB: Lofexidine HCl 3.2mg Dose
n=222 Participants
Participants were randomized to receive 3.2 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 3.2 mg for up to 7 days.
|
DB: Placebo
n=151 Participants
Participants were randomized to receive placebo during the double-blind period of the study. Subjects will take 4 tablets QID for up to 7 days.
Placebo: Lofexidine-matching tablets without the active pharmaceutical ingredient will be provided as 4 tablets QID during the double-blind portion of the study to subjects randomized to placebo.
|
Total
n=602 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
35 years
STANDARD_DEVIATION 10.5 • n=107 Participants
|
36 years
STANDARD_DEVIATION 11.9 • n=206 Participants
|
35 years
STANDARD_DEVIATION 11.0 • n=157 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
175 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
162 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
427 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
83 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
196 Participants
n=99 Participants
|
194 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
519 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
54 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
128 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
169 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
444 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
16 Participants
n=157 Participants
|
|
Body weight
|
76.0 kg
STANDARD_DEVIATION 16.88 • n=99 Participants
|
76.1 kg
STANDARD_DEVIATION 16.59 • n=107 Participants
|
76.0 kg
STANDARD_DEVIATION 14.94 • n=206 Participants
|
76.1 kg
STANDARD_DEVIATION 16.29 • n=157 Participants
|
|
BMI (kg/m^2)
|
25.1 kg/m^2
STANDARD_DEVIATION 4.71 • n=99 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 5.32 • n=107 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 4.63 • n=206 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 4.92 • n=157 Participants
|
PRIMARY outcome
Timeframe: Days 1 through 7Population: mITT population Participants Analyzed does not match the Participant Flow because of missing data.
The SOWS-Gossop was completed by the mITT population subject at baseline, once daily at 3.5 hours after the first dose of the study medication on Days 1 to 7. It consists of 10 items that are scored on a 4-point scale; 0=none, 1=mild, 2=moderate, and 3=severe. The overall score is the simple sum of the 10-item scores (minimum overall score of 0, maximum score of 30). Higher individual scores on the scale indicate greater symptom severity. However, as the outcome measure is a difference from placebo, a lower number indicates a better outcome. mITT population: all randomized subjects who received at least 1 dose of study medication
Outcome measures
| Measure |
DB: Lofexidine HCl 2.4mg Dose
n=229 Participants
Participants were randomized to receive 2.4 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 2.4 mg (one tablet in each dose will be a placebo tablet to maintain the blind) for up to 7 days.
|
DB: Lofexidine HCl 3.2mg Dose
n=222 Participants
Participants were randomized to receive 3.2 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 3.2 mg for up to 7 days.
|
DB: Placebo
n=151 Participants
Participants were randomized to receive placebo during the double-blind period of the study. Subjects will take 4 tablets QID for up to 7 days.
Placebo: Lofexidine-matching tablets without the active pharmaceutical ingredient will be provided as 4 tablets QID during the double-blind portion of the study to subjects randomized to placebo.
|
|---|---|---|---|
|
Difference Between the Overall Means From Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) Scores
Day 1
|
7.8 score on a scale
Standard Deviation 6.00
|
7.6 score on a scale
Standard Deviation 6.75
|
9.4 score on a scale
Standard Deviation 6.81
|
|
Difference Between the Overall Means From Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) Scores
Day 2
|
10.2 score on a scale
Standard Deviation 6.83
|
9.9 score on a scale
Standard Deviation 7.38
|
13.9 score on a scale
Standard Deviation 8.29
|
|
Difference Between the Overall Means From Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) Scores
Day 3
|
7.6 score on a scale
Standard Deviation 5.53
|
7.4 score on a scale
Standard Deviation 6.34
|
10.9 score on a scale
Standard Deviation 6.76
|
|
Difference Between the Overall Means From Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) Scores
Day 4
|
5.7 score on a scale
Standard Deviation 5.32
|
5.5 score on a scale
Standard Deviation 5.36
|
9.2 score on a scale
Standard Deviation 6.81
|
|
Difference Between the Overall Means From Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) Scores
Day 5
|
4.7 score on a scale
Standard Deviation 4.60
|
4.5 score on a scale
Standard Deviation 4.96
|
6.4 score on a scale
Standard Deviation 5.91
|
|
Difference Between the Overall Means From Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) Scores
Day 6
|
3.6 score on a scale
Standard Deviation 3.97
|
3.2 score on a scale
Standard Deviation 4.10
|
4.4 score on a scale
Standard Deviation 5.80
|
|
Difference Between the Overall Means From Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) Scores
Day 7
|
2.7 score on a scale
Standard Deviation 3.45
|
2.3 score on a scale
Standard Deviation 3.23
|
2.7 score on a scale
Standard Deviation 4.60
|
SECONDARY outcome
Timeframe: Day 7Population: The percentage of subjects in each treatment arm who complete the double-blind phase of the study (defined as those who receive at least one dose of study medication on Day 7 and complete the 3.5 hour post-dose SOWS-Gossop assessment on Day 7).
The percentage of subjects in each treatment arm who receive at least one dose of study medication on Day 7 and complete the 3.5 hour post-dose SOWS-Gossop assessment on Day 7.
Outcome measures
| Measure |
DB: Lofexidine HCl 2.4mg Dose
n=229 Participants
Participants were randomized to receive 2.4 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 2.4 mg (one tablet in each dose will be a placebo tablet to maintain the blind) for up to 7 days.
|
DB: Lofexidine HCl 3.2mg Dose
n=222 Participants
Participants were randomized to receive 3.2 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 3.2 mg for up to 7 days.
|
DB: Placebo
n=151 Participants
Participants were randomized to receive placebo during the double-blind period of the study. Subjects will take 4 tablets QID for up to 7 days.
Placebo: Lofexidine-matching tablets without the active pharmaceutical ingredient will be provided as 4 tablets QID during the double-blind portion of the study to subjects randomized to placebo.
|
|---|---|---|---|
|
Completion Status
Yes/Complete
|
95 Participants
|
88 Participants
|
42 Participants
|
|
Completion Status
No/Did Not Complete
|
134 Participants
|
134 Participants
|
109 Participants
|
Adverse Events
DB: Lofexidine HCl 2.4mg Dose
Serious events: 0 serious events
Other events: 216 other events
Deaths: 0 deaths
DB: Lofexidine HCl 3.2mg Dose
Serious events: 5 serious events
Other events: 211 other events
Deaths: 1 deaths
DB: Placebo
Serious events: 2 serious events
Other events: 134 other events
Deaths: 0 deaths
OL: All Lofexidine HCl
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB: Lofexidine HCl 2.4mg Dose
n=229 participants at risk
Participants were randomized to receive 2.4 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 2.4 mg (one tablet in each dose will be a placebo tablet to maintain the blind) for up to 7 days.
|
DB: Lofexidine HCl 3.2mg Dose
n=222 participants at risk
Participants were randomized to receive 3.2 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 3.2 mg for up to 7 days.
|
DB: Placebo
n=151 participants at risk
Participants were randomized to receive placebo during the double-blind period of the study. Subjects will take 4 tablets QID for up to 7 days.
Placebo: Lofexidine-matching tablets without the active pharmaceutical ingredient will be provided as 4 tablets QID during the double-blind portion of the study to subjects randomized to placebo.
|
OL: All Lofexidine HCl
n=83 participants at risk
Participants were given the option to receive lofexidine HCl tablets for up to 7 additional days, following the double blind period. Dosing regimens are at the discretion of the Investigator, but total daily dose will not exceed 3.2 mg.
|
|---|---|---|---|---|
|
Infections and infestations
Acute hepatitis C
|
0.00%
0/229 • Through study completion (14 Days)
|
0.00%
0/222 • Through study completion (14 Days)
|
0.66%
1/151 • Through study completion (14 Days)
|
0.00%
0/83 • Through study completion (14 Days)
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/229 • Through study completion (14 Days)
|
0.45%
1/222 • Through study completion (14 Days)
|
0.00%
0/151 • Through study completion (14 Days)
|
0.00%
0/83 • Through study completion (14 Days)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/229 • Through study completion (14 Days)
|
0.45%
1/222 • Through study completion (14 Days)
|
0.00%
0/151 • Through study completion (14 Days)
|
0.00%
0/83 • Through study completion (14 Days)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/229 • Through study completion (14 Days)
|
0.00%
0/222 • Through study completion (14 Days)
|
0.66%
1/151 • Through study completion (14 Days)
|
0.00%
0/83 • Through study completion (14 Days)
|
|
Nervous system disorders
Syncope
|
0.00%
0/229 • Through study completion (14 Days)
|
0.90%
2/222 • Through study completion (14 Days)
|
0.00%
0/151 • Through study completion (14 Days)
|
0.00%
0/83 • Through study completion (14 Days)
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/229 • Through study completion (14 Days)
|
0.45%
1/222 • Through study completion (14 Days)
|
0.00%
0/151 • Through study completion (14 Days)
|
0.00%
0/83 • Through study completion (14 Days)
|
Other adverse events
| Measure |
DB: Lofexidine HCl 2.4mg Dose
n=229 participants at risk
Participants were randomized to receive 2.4 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 2.4 mg (one tablet in each dose will be a placebo tablet to maintain the blind) for up to 7 days.
|
DB: Lofexidine HCl 3.2mg Dose
n=222 participants at risk
Participants were randomized to receive 3.2 mg total daily dose of lofexidine HCl during the double-blind period of the study. Subjects will take 4 tablets QID for a total daily dose of 3.2 mg for up to 7 days.
|
DB: Placebo
n=151 participants at risk
Participants were randomized to receive placebo during the double-blind period of the study. Subjects will take 4 tablets QID for up to 7 days.
Placebo: Lofexidine-matching tablets without the active pharmaceutical ingredient will be provided as 4 tablets QID during the double-blind portion of the study to subjects randomized to placebo.
|
OL: All Lofexidine HCl
n=83 participants at risk
Participants were given the option to receive lofexidine HCl tablets for up to 7 additional days, following the double blind period. Dosing regimens are at the discretion of the Investigator, but total daily dose will not exceed 3.2 mg.
|
|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
23.6%
54/229 • Through study completion (14 Days)
|
31.5%
70/222 • Through study completion (14 Days)
|
5.3%
8/151 • Through study completion (14 Days)
|
3.6%
3/83 • Through study completion (14 Days)
|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
9/229 • Through study completion (14 Days)
|
2.3%
5/222 • Through study completion (14 Days)
|
6.0%
9/151 • Through study completion (14 Days)
|
0.00%
0/83 • Through study completion (14 Days)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
19/229 • Through study completion (14 Days)
|
8.1%
18/222 • Through study completion (14 Days)
|
7.9%
12/151 • Through study completion (14 Days)
|
4.8%
4/83 • Through study completion (14 Days)
|
|
Gastrointestinal disorders
Diarrhoea
|
22.3%
51/229 • Through study completion (14 Days)
|
21.6%
48/222 • Through study completion (14 Days)
|
23.2%
35/151 • Through study completion (14 Days)
|
6.0%
5/83 • Through study completion (14 Days)
|
|
Gastrointestinal disorders
Dry mouth
|
9.6%
22/229 • Through study completion (14 Days)
|
10.8%
24/222 • Through study completion (14 Days)
|
1.3%
2/151 • Through study completion (14 Days)
|
4.8%
4/83 • Through study completion (14 Days)
|
|
Gastrointestinal disorders
Constipation
|
6.1%
14/229 • Through study completion (14 Days)
|
7.7%
17/222 • Through study completion (14 Days)
|
2.6%
4/151 • Through study completion (14 Days)
|
2.4%
2/83 • Through study completion (14 Days)
|
|
Gastrointestinal disorders
Nausea
|
21.8%
50/229 • Through study completion (14 Days)
|
12.2%
27/222 • Through study completion (14 Days)
|
21.2%
32/151 • Through study completion (14 Days)
|
0.00%
0/83 • Through study completion (14 Days)
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
23/229 • Through study completion (14 Days)
|
8.6%
19/222 • Through study completion (14 Days)
|
15.9%
24/151 • Through study completion (14 Days)
|
1.2%
1/83 • Through study completion (14 Days)
|
|
General disorders
Pain
|
22.3%
51/229 • Through study completion (14 Days)
|
18.9%
42/222 • Through study completion (14 Days)
|
23.8%
36/151 • Through study completion (14 Days)
|
4.8%
4/83 • Through study completion (14 Days)
|
|
General disorders
Drug withdrawal syndrome
|
6.1%
14/229 • Through study completion (14 Days)
|
6.3%
14/222 • Through study completion (14 Days)
|
4.6%
7/151 • Through study completion (14 Days)
|
0.00%
0/83 • Through study completion (14 Days)
|
|
General disorders
Fatigue
|
6.1%
14/229 • Through study completion (14 Days)
|
7.2%
16/222 • Through study completion (14 Days)
|
4.0%
6/151 • Through study completion (14 Days)
|
3.6%
3/83 • Through study completion (14 Days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
9/229 • Through study completion (14 Days)
|
4.1%
9/222 • Through study completion (14 Days)
|
6.0%
9/151 • Through study completion (14 Days)
|
2.4%
2/83 • Through study completion (14 Days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.1%
30/229 • Through study completion (14 Days)
|
9.9%
22/222 • Through study completion (14 Days)
|
16.6%
25/151 • Through study completion (14 Days)
|
1.2%
1/83 • Through study completion (14 Days)
|
|
Nervous system disorders
Headache
|
13.1%
30/229 • Through study completion (14 Days)
|
14.0%
31/222 • Through study completion (14 Days)
|
15.2%
23/151 • Through study completion (14 Days)
|
4.8%
4/83 • Through study completion (14 Days)
|
|
Nervous system disorders
Sedation
|
12.7%
29/229 • Through study completion (14 Days)
|
12.2%
27/222 • Through study completion (14 Days)
|
5.3%
8/151 • Through study completion (14 Days)
|
1.2%
1/83 • Through study completion (14 Days)
|
|
Nervous system disorders
Dizziness
|
19.2%
44/229 • Through study completion (14 Days)
|
23.0%
51/222 • Through study completion (14 Days)
|
2.6%
4/151 • Through study completion (14 Days)
|
3.6%
3/83 • Through study completion (14 Days)
|
|
Nervous system disorders
Somnolence
|
10.9%
25/229 • Through study completion (14 Days)
|
13.1%
29/222 • Through study completion (14 Days)
|
5.3%
8/151 • Through study completion (14 Days)
|
0.00%
0/83 • Through study completion (14 Days)
|
|
Psychiatric disorders
Anxiety
|
4.4%
10/229 • Through study completion (14 Days)
|
4.5%
10/222 • Through study completion (14 Days)
|
6.6%
10/151 • Through study completion (14 Days)
|
6.0%
5/83 • Through study completion (14 Days)
|
|
Psychiatric disorders
Insomnia
|
51.1%
117/229 • Through study completion (14 Days)
|
55.4%
123/222 • Through study completion (14 Days)
|
48.3%
73/151 • Through study completion (14 Days)
|
4.8%
4/83 • Through study completion (14 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.5%
8/229 • Through study completion (14 Days)
|
2.7%
6/222 • Through study completion (14 Days)
|
6.0%
9/151 • Through study completion (14 Days)
|
1.2%
1/83 • Through study completion (14 Days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
13/229 • Through study completion (14 Days)
|
3.6%
8/222 • Through study completion (14 Days)
|
2.6%
4/151 • Through study completion (14 Days)
|
0.00%
0/83 • Through study completion (14 Days)
|
|
Vascular disorders
Hypertension
|
1.3%
3/229 • Through study completion (14 Days)
|
3.2%
7/222 • Through study completion (14 Days)
|
9.9%
15/151 • Through study completion (14 Days)
|
1.2%
1/83 • Through study completion (14 Days)
|
|
Vascular disorders
Hypotension
|
30.1%
69/229 • Through study completion (14 Days)
|
30.2%
67/222 • Through study completion (14 Days)
|
1.3%
2/151 • Through study completion (14 Days)
|
8.4%
7/83 • Through study completion (14 Days)
|
|
Vascular disorders
Orthostatic hypotension
|
29.3%
67/229 • Through study completion (14 Days)
|
42.3%
94/222 • Through study completion (14 Days)
|
4.6%
7/151 • Through study completion (14 Days)
|
4.8%
4/83 • Through study completion (14 Days)
|
|
Cardiac disorders
Tachycardia
|
2.6%
6/229 • Through study completion (14 Days)
|
0.90%
2/222 • Through study completion (14 Days)
|
8.6%
13/151 • Through study completion (14 Days)
|
6.0%
5/83 • Through study completion (14 Days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place