Trial Outcomes & Findings for Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin (NCT NCT03841331)
NCT ID: NCT03841331
Last Updated: 2021-05-20
Results Overview
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
COMPLETED
PHASE2
233 participants
At Week 10
2021-05-20
Participant Flow
The study was conducted at 41 sites in US from 22 January 2019 to 21 January 2020. All subjects who met the study entry criteria were randomized in a 1:1 ratio to receive daily oral doses of serlopitant 5 mg or placebo.
During the screening period (3 weeks), all subjects were evaluated for eligibility and assessed for conditions associated with chronic pruritus. Subjects were to complete an electronic diary (eDiary) at the Screening visit.
Participant milestones
| Measure |
Placebo
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
116
|
|
Overall Study
COMPLETED
|
108
|
106
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
Placebo
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
9
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
Baseline Characteristics
Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
Baseline characteristics by cohort
| Measure |
Placebo
n=117 Participants
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
n=116 Participants
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 12.05 • n=39 Participants
|
60.7 years
STANDARD_DEVIATION 13.60 • n=41 Participants
|
59.4 years
STANDARD_DEVIATION 12.89 • n=35 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=39 Participants
|
83 Participants
n=41 Participants
|
176 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
57 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=39 Participants
|
102 Participants
n=41 Participants
|
197 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: At Week 10Population: Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
Outcome measures
| Measure |
Placebo
n=117 Participants
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
n=116 Participants
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
|---|---|---|
|
Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10
|
46 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: At Weeks 2, 4, 6, and 8Population: Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
Outcome measures
| Measure |
Placebo
n=117 Participants
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
n=116 Participants
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
|---|---|---|
|
WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8
Responders at Week 2
|
19 Participants
|
18 Participants
|
|
WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8
Responders at Week 4
|
29 Participants
|
24 Participants
|
|
WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8
Responders at Week 6
|
35 Participants
|
38 Participants
|
|
WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8
Responders at Week 8
|
40 Participants
|
37 Participants
|
PRIMARY outcome
Timeframe: At Weeks 2, 4, 6, 8, and 10Population: Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder.
Outcome measures
| Measure |
Placebo
n=117 Participants
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
n=116 Participants
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
|---|---|---|
|
WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10
Responders at Week 10
|
13 Participants
|
16 Participants
|
|
WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10
Responders at Week 2
|
6 Participants
|
6 Participants
|
|
WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10
Responders at Week 4
|
8 Participants
|
14 Participants
|
|
WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10
Responders at Week 6
|
15 Participants
|
10 Participants
|
|
WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10
Responders at Week 8
|
14 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: At Weeks 2, 4, 6, 8, and 10Population: Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.
Outcome measures
| Measure |
Placebo
n=117 Participants
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
n=116 Participants
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
|---|---|---|
|
Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10
Change from Basline at Week 8
|
-2.99 score on a scale
Standard Deviation 2.647
|
-2.97 score on a scale
Standard Deviation 2.562
|
|
Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10
Change from Baseline at Week 10
|
-3.34 score on a scale
Standard Deviation 2.787
|
-3.25 score on a scale
Standard Deviation 2.545
|
|
Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10
Baseline (Observed value)
|
8.37 score on a scale
Standard Deviation 0.929
|
8.44 score on a scale
Standard Deviation 0.855
|
|
Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10
Change from Baseline at Week 2
|
-1.65 score on a scale
Standard Deviation 2.115
|
-1.61 score on a scale
Standard Deviation 1.961
|
|
Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10
Change from Baseline at Week 4
|
-2.41 score on a scale
Standard Deviation 2.382
|
-2.46 score on a scale
Standard Deviation 2.349
|
|
Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10
Change from Baseline at Week 6
|
-2.83 score on a scale
Standard Deviation 2.624
|
-2.94 score on a scale
Standard Deviation 2.495
|
PRIMARY outcome
Timeframe: Through 2 weeksPopulation: Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.
Outcome measures
| Measure |
Placebo
n=117 Participants
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
n=116 Participants
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
|---|---|---|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 1
|
-0.22 score on a scale
Standard Deviation 0.879
|
-0.09 score on a scale
Standard Deviation 0.819
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 2
|
-0.85 score on a scale
Standard Deviation 1.836
|
-0.69 score on a scale
Standard Deviation 1.264
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 3
|
-0.94 score on a scale
Standard Deviation 1.788
|
-0.77 score on a scale
Standard Deviation 1.348
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 4
|
-1.16 score on a scale
Standard Deviation 1.977
|
-0.96 score on a scale
Standard Deviation 1.459
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 9
|
-1.53 score on a scale
Standard Deviation 2.210
|
-1.35 score on a scale
Standard Deviation 1.996
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Baseline (observed value)
|
8.37 score on a scale
Standard Deviation 0.929
|
8.44 score on a scale
Standard Deviation 0.855
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 5
|
-1.34 score on a scale
Standard Deviation 2.103
|
-0.99 score on a scale
Standard Deviation 1.495
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 6
|
-1.33 score on a scale
Standard Deviation 2.174
|
-1.15 score on a scale
Standard Deviation 1.892
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 7
|
-1.44 score on a scale
Standard Deviation 2.331
|
-1.35 score on a scale
Standard Deviation 1.758
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 8
|
-1.35 score on a scale
Standard Deviation 2.171
|
-1.35 score on a scale
Standard Deviation 1.746
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 10
|
-1.63 score on a scale
Standard Deviation 2.460
|
-1.41 score on a scale
Standard Deviation 2.023
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 11
|
-1.73 score on a scale
Standard Deviation 2.333
|
-1.69 score on a scale
Standard Deviation 2.211
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 12
|
-1.67 score on a scale
Standard Deviation 2.280
|
-1.58 score on a scale
Standard Deviation 2.247
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 13
|
-1.82 score on a scale
Standard Deviation 2.335
|
-1.75 score on a scale
Standard Deviation 2.291
|
|
Change From Baseline in Daily WI-NRS Scores Through Week 2
Change from Baseline at Day 14
|
-1.92 score on a scale
Standard Deviation 2.518
|
-1.74 score on a scale
Standard Deviation 2.266
|
PRIMARY outcome
Timeframe: At Weeks 2, 4, 6, and 10Population: Full Analysis Population: subset of subjects in the randomized population who were dispensed study medication.
The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits.
Outcome measures
| Measure |
Placebo
n=117 Participants
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
n=116 Participants
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
|---|---|---|
|
Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10
Baseline (Observed Value)
|
82.09 score on a scale
Standard Deviation 10.741
|
83.53 score on a scale
Standard Deviation 11.941
|
|
Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10
Change from Baseline at Week 2
|
-22.96 score on a scale
Standard Deviation 27.425
|
-20.52 score on a scale
Standard Deviation 28.825
|
|
Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10
Change from Baseline at Week 4
|
-27.01 score on a scale
Standard Deviation 28.906
|
-28.28 score on a scale
Standard Deviation 29.731
|
|
Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10
Change from Baseline at Week 6
|
-32.83 score on a scale
Standard Deviation 31.046
|
-30.92 score on a scale
Standard Deviation 31.487
|
|
Change From Baseline in Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10
Change from Baseline at Week 10
|
-37.64 score on a scale
Standard Deviation 31.613
|
-37.42 score on a scale
Standard Deviation 32.986
|
SECONDARY outcome
Timeframe: From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.Population: Safety Population - Subset of subjects who received at least one dose of study medication
Adverse events (AEs) were recorded to assess the safety and tolerability of repeated oral doses of serlopitant in adult subjects with chronic pruritus of unknown origin. Adverse events (AEs) and SAEs were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
Outcome measures
| Measure |
Placebo
n=117 Participants
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
n=116 Participants
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs Leading to Treatment Discontinuation
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs Likely Related to Study Drug
|
3 Participants
|
12 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
38 Participants
|
49 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Serious TEAEs
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Week 10The plasma concentrations of serlopitant and metabolites were combined with the data from other serlopitant clinical studies for population pharmacokinetic analysis.
Outcome measures
| Measure |
Placebo
n=117 Participants
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
n=116 Participants
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
|---|---|---|
|
Plasma Concentrations of Serlopitant and Metabolites
Met-Serl-M1/M1a
|
0.2 nmol/L
Standard Deviation 2.02
|
150.8 nmol/L
Standard Deviation 120.33
|
|
Plasma Concentrations of Serlopitant and Metabolites
Met-Serl-M2/M2a
|
0.1 nmol/L
Standard Deviation 0.81
|
41.6 nmol/L
Standard Deviation 26.69
|
|
Plasma Concentrations of Serlopitant and Metabolites
Met-Serl-M3
|
0.0 nmol/L
Standard Deviation 0.46
|
60.9 nmol/L
Standard Deviation 39.43
|
|
Plasma Concentrations of Serlopitant and Metabolites
Serlopitant
|
0.3 nmol/L
Standard Deviation 3.09
|
634.6 nmol/L
Standard Deviation 441.07
|
Adverse Events
Placebo
Serlopitant 5 mg
Serious adverse events
| Measure |
Placebo
n=117 participants at risk
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
n=116 participants at risk
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
|---|---|---|
|
Nervous system disorders
Intracranial mass
|
0.00%
0/117 • From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
|
0.86%
1/116 • Number of events 1 • From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/117 • From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
|
0.86%
1/116 • Number of events 1 • From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/117 • From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
|
0.86%
1/116 • Number of events 1 • From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
|
Other adverse events
| Measure |
Placebo
n=117 participants at risk
Randomized subjects received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
Serlopitant 5 mg
n=116 participants at risk
Randomized subjects received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, subjects took 1 tablet per day until the completion of the 10-week treatment period.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/117 • From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
|
6.9%
8/116 • From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
|
|
Nervous system disorders
Somnolence
|
0.85%
1/117 • From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
|
5.2%
6/116 • From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for subjects who discontinued study drug early.
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol-mandated intervention were collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60