Trial Outcomes & Findings for Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis (NCT NCT05185089)
NCT ID: NCT05185089
Last Updated: 2025-11-10
Results Overview
A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for coughing severity in the last 24 hours
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Week 4
Results posted on
2025-11-10
Participant Flow
80 participants were enrolled into the study. 40 were randomised to the orvepitant 10 mg cohort and 40 to the orvepitant 30 mg cohort.
This was a crossover study so each participant was to receive both orvepitant and placebo.
Participant milestones
| Measure |
Placebo first, then orvepitant 10 mg
Participants first received placebo once-daily (one tablet each evening, matching orvepitant 10 mg) for 4 weeks (Period A). After a washout period of 3 weeks, they then received orvepitant 10mg once-daily (one tablet each evening) for 4 weeks (Period B).
|
Orvepitant 10 mg first, then placebo
Participants first received orvepitant 10mg once-daily (one tablet each evening) for 4 weeks (Period A). After a washout period of 3 weeks, they then received placebo once-daily (one tablet each evening, matching orvepitant 10 mg) for 4 weeks (Period B).
|
Placebo first, then orvepitant 30 mg
Participants first received placebo once-daily (one tablet each evening, matching orvepitant 30 mg) for 4 weeks (Period A). After a washout period of 3 weeks, they then received orvepitant 30mg once-daily (one tablet each evening) for 4 weeks (Period B).
|
Orvepitant 30 mg first, then placebo
Participants first received orvepitant 30mg once-daily (one tablet each evening) for 4 weeks (Period A). After a washout period of 3 weeks, they then received placebo once-daily (one tablet each evening, matching orvepitant 30 mg) for 4 weeks (Period B).
|
|---|---|---|---|---|
|
First Intervention (4 weeks)
STARTED
|
20
|
20
|
20
|
20
|
|
First Intervention (4 weeks)
COMPLETED
|
20
|
20
|
20
|
19
|
|
First Intervention (4 weeks)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Washout (3 weeks)
STARTED
|
20
|
20
|
20
|
19
|
|
Washout (3 weeks)
COMPLETED
|
20
|
20
|
20
|
19
|
|
Washout (3 weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention (4 weeks)
STARTED
|
20
|
20
|
20
|
19
|
|
Second Intervention (4 weeks)
COMPLETED
|
19
|
19
|
20
|
19
|
|
Second Intervention (4 weeks)
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo first, then orvepitant 10 mg
Participants first received placebo once-daily (one tablet each evening, matching orvepitant 10 mg) for 4 weeks (Period A). After a washout period of 3 weeks, they then received orvepitant 10mg once-daily (one tablet each evening) for 4 weeks (Period B).
|
Orvepitant 10 mg first, then placebo
Participants first received orvepitant 10mg once-daily (one tablet each evening) for 4 weeks (Period A). After a washout period of 3 weeks, they then received placebo once-daily (one tablet each evening, matching orvepitant 10 mg) for 4 weeks (Period B).
|
Placebo first, then orvepitant 30 mg
Participants first received placebo once-daily (one tablet each evening, matching orvepitant 30 mg) for 4 weeks (Period A). After a washout period of 3 weeks, they then received orvepitant 30mg once-daily (one tablet each evening) for 4 weeks (Period B).
|
Orvepitant 30 mg first, then placebo
Participants first received orvepitant 30mg once-daily (one tablet each evening) for 4 weeks (Period A). After a washout period of 3 weeks, they then received placebo once-daily (one tablet each evening, matching orvepitant 30 mg) for 4 weeks (Period B).
|
|---|---|---|---|---|
|
First Intervention (4 weeks)
Adverse Event
|
0
|
0
|
0
|
1
|
|
Second Intervention (4 weeks)
Death
|
0
|
1
|
0
|
0
|
|
Second Intervention (4 weeks)
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
Orvepitant 10 mg Cohort
n=40 Participants
Participants randomised to the orvepitant 10 mg cohort. They were randomised to receive either orvepitant 10 mg or placebo in the first treatment period (Treatment Period A), followed by the alternate treatment in Treatment Period B.
|
Orvepitant 30 mg Cohort
n=40 Participants
Participants randomised to the orvepitant 30 mg cohort. They were randomised to receive either orvepitant 30 mg or placebo in the first treatment period (Treatment Period A), followed by the alternate treatment in Treatment Period B.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.4 Years
STANDARD_DEVIATION 6.55 • n=5 Participants
|
72.4 Years
STANDARD_DEVIATION 7.79 • n=20 Participants
|
71.9 Years
STANDARD_DEVIATION 7.17 • n=40 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
29 Participants
n=20 Participants
|
59 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
37 Participants
n=20 Participants
|
77 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
37 Participants
n=20 Participants
|
74 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Week 4A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for coughing severity in the last 24 hours
Outcome measures
| Measure |
Orvepitant 30 mg
n=39 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=39 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS)
|
-0.85 Points
Standard Deviation 1.465
|
-0.69 Points
Standard Deviation 1.583
|
-0.66 Points
Standard Deviation 1.276
|
-0.26 Points
Standard Deviation 1.155
|
SECONDARY outcome
Timeframe: Week 4A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for coughing severity first thing in the morning
Outcome measures
| Measure |
Orvepitant 30 mg
n=39 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=39 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Weekly Average of the Early Morning IPF Coughing Severity Scale
|
-1.08 Points
Standard Deviation 1.627
|
-0.57 Points
Standard Deviation 1.505
|
-0.51 Points
Standard Deviation 1.199
|
-0.49 Points
Standard Deviation 1.184
|
SECONDARY outcome
Timeframe: Week 4A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for severity of any other coughing during the last 24 hours, excluding coughing first thing in the morning
Outcome measures
| Measure |
Orvepitant 30 mg
n=39 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=39 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Weekly Average of the Rest of the Day IPF Coughing Severity Scale
|
-0.80 Points
Standard Deviation 1.528
|
-0.62 Points
Standard Deviation 1.477
|
-0.62 Points
Standard Deviation 1.306
|
-0.44 Points
Standard Deviation 1.117
|
SECONDARY outcome
Timeframe: Week 4A numerical rating scale from 0 (no urge to cough) to 10 (urge to cough as bad as you can imagine) for severity of urge to cough in the last 24 hours
Outcome measures
| Measure |
Orvepitant 30 mg
n=39 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=39 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Weekly Average of the Daily Urge to Cough Scale
|
-0.76 Points
Standard Deviation 1.400
|
-0.46 Points
Standard Deviation 1.517
|
-0.63 Points
Standard Deviation 1.209
|
-0.30 Points
Standard Deviation 0.974
|
SECONDARY outcome
Timeframe: Week 4A 5-point verbal rating scale for cough frequency over the last 24 hours with response options from 'never' to 'all the time'. The verbal responses were converted to a number (0 = never, 4 = all the time).
Outcome measures
| Measure |
Orvepitant 30 mg
n=39 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=39 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Weekly Average of the Daily Cough Frequency Scale
|
-0.29 Points
Standard Deviation 0.462
|
-0.20 Points
Standard Deviation 0.574
|
-0.15 Points
Standard Deviation 0.543
|
-0.06 Points
Standard Deviation 0.369
|
SECONDARY outcome
Timeframe: Week 4A numerical rating scale from 0 (no shortness of breath) to 10 (shortness of breath as bad as you can imagine) for severity of shortness of breath in the last 24 hours
Outcome measures
| Measure |
Orvepitant 30 mg
n=39 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=39 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Weekly Average of the Daily Dyspnoea Scale
|
-0.44 Points
Standard Deviation 1.060
|
-0.26 Points
Standard Deviation 1.192
|
-0.22 Points
Standard Deviation 0.988
|
0.00 Points
Standard Deviation 0.764
|
SECONDARY outcome
Timeframe: Week 4The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the total score.
Outcome measures
| Measure |
Orvepitant 30 mg
n=39 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=39 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score
|
1.60 Points
Standard Deviation 2.353
|
1.07 Points
Standard Deviation 2.218
|
1.27 Points
Standard Deviation 2.187
|
0.14 Points
Standard Deviation 2.724
|
SECONDARY outcome
Timeframe: Week 4The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the physical domain score.
Outcome measures
| Measure |
Orvepitant 30 mg
n=39 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=39 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Physical Domain Score
|
0.36 Points
Standard Deviation 0.638
|
0.18 Points
Standard Deviation 0.656
|
0.26 Points
Standard Deviation 0.717
|
0.06 Points
Standard Deviation 0.750
|
SECONDARY outcome
Timeframe: Week 4The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the psychological domain score.
Outcome measures
| Measure |
Orvepitant 30 mg
n=39 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=39 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Psychological Domain Score
|
0.63 Points
Standard Deviation 0.984
|
0.57 Points
Standard Deviation 0.935
|
0.47 Points
Standard Deviation 0.906
|
0.12 Points
Standard Deviation 1.004
|
SECONDARY outcome
Timeframe: Week 4The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the social domain score.
Outcome measures
| Measure |
Orvepitant 30 mg
n=39 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=39 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=39 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Social Domain Score
|
0.60 Points
Standard Deviation 1.068
|
0.32 Points
Standard Deviation 0.885
|
0.54 Points
Standard Deviation 0.950
|
-0.03 Points
Standard Deviation 1.202
|
SECONDARY outcome
Timeframe: Week 4Population: Fewer participants analyzed than assigned to the groups as some had insufficient recordings.
Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor)
Outcome measures
| Measure |
Orvepitant 30 mg
n=32 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=32 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=31 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=32 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in 24-hour Cough Frequency
|
0.87 Coughs/hour ratio vs baseline
Standard Error 1.112
|
0.93 Coughs/hour ratio vs baseline
Standard Error 1.114
|
1.00 Coughs/hour ratio vs baseline
Standard Error 1.115
|
0.84 Coughs/hour ratio vs baseline
Standard Error 1.113
|
SECONDARY outcome
Timeframe: Week 4Population: Fewer participants analyzed than assigned to the groups as some had insufficient recordings.
Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor)
Outcome measures
| Measure |
Orvepitant 30 mg
n=32 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=32 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=31 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=32 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Awake Cough Frequency
|
0.87 Awake coughs/hour ratio vs baseline
Standard Error 1.121
|
0.95 Awake coughs/hour ratio vs baseline
Standard Error 1.119
|
1.03 Awake coughs/hour ratio vs baseline
Standard Error 1.121
|
0.84 Awake coughs/hour ratio vs baseline
Standard Error 1.122
|
SECONDARY outcome
Timeframe: Week 4Population: Fewer participants analyzed than assigned to the groups as some had insufficient recordings.
Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor)
Outcome measures
| Measure |
Orvepitant 30 mg
n=29 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=31 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=29 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=29 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in Night-time Cough Frequency
|
0.85 Asleep coughs/hour ratio vs baseline
Standard Error 1.145
|
0.79 Asleep coughs/hour ratio vs baseline
Standard Error 1.180
|
0.90 Asleep coughs/hour ratio vs baseline
Standard Error 1.184
|
0.87 Asleep coughs/hour ratio vs baseline
Standard Error 1.149
|
SECONDARY outcome
Timeframe: Week 4Population: Fewer participants analyzed than assigned to the groups as some had insufficient recordings.
Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor)
Outcome measures
| Measure |
Orvepitant 30 mg
n=32 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=32 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=31 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=32 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Number of Coughing Bouts
|
0.88 Bouts/hour ratio vs baseline
Standard Error 1.087
|
0.91 Bouts/hour ratio vs baseline
Standard Error 1.089
|
1.00 Bouts/hour ratio vs baseline
Standard Error 1.090
|
0.82 Bouts/hour ratio vs baseline
Standard Error 1.087
|
SECONDARY outcome
Timeframe: Week 4Population: Fewer participants analyzed than assigned to the groups as some had insufficient recordings.
Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor)
Outcome measures
| Measure |
Orvepitant 30 mg
n=32 Participants
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (10 mg Cohort)
n=30 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=30 Participants
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=32 Participants
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Number of Coughs Per Bout
|
0.89 Coughs per bout ratio vs baseline
Standard Error 1.028
|
0.91 Coughs per bout ratio vs baseline
Standard Error 1.027
|
0.92 Coughs per bout ratio vs baseline
Standard Error 1.027
|
0.98 Coughs per bout ratio vs baseline
Standard Error 1.028
|
Adverse Events
Placebo (10 mg Cohort)
Serious events: 2 serious events
Other events: 18 other events
Deaths: 1 deaths
Orvepitant 10 mg
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo (30 mg Cohort)
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Orvepitant 30 mg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (10 mg Cohort)
n=40 participants at risk
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=40 participants at risk
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=38 participants at risk
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
Orvepitant 30 mg
n=39 participants at risk
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis (exacerbation)
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.5%
1/40 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/38 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/39 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
2.5%
1/40 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/38 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/39 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.5%
1/40 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/38 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/39 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/38 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/39 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Gastrointestinal disorders
Obstructive pancreatitis (secondary to gallstones)
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/38 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/39 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Infections and infestations
COVID-19
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/38 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/39 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Investigations
Oxygen saturation decreased (due to no oxygen delivery)
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/38 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/39 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/38 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/39 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
Other adverse events
| Measure |
Placebo (10 mg Cohort)
n=40 participants at risk
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort)
|
Orvepitant 10 mg
n=40 participants at risk
Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B
|
Placebo (30 mg Cohort)
n=38 participants at risk
Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort)
|
Orvepitant 30 mg
n=39 participants at risk
Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.5%
1/40 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
7.5%
3/40 • Number of events 3 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
10.5%
4/38 • Number of events 4 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/39 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
7.5%
3/40 • Number of events 3 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.3%
2/38 • Number of events 3 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.1%
2/39 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Infections and infestations
COVID-19
|
2.5%
1/40 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.5%
1/40 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/38 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.1%
2/39 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.0%
2/40 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/38 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
7.7%
3/39 • Number of events 3 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
2/40 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.3%
2/38 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
7.7%
3/39 • Number of events 3 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/38 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.1%
2/39 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.3%
2/38 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/39 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
2/40 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
10.0%
4/40 • Number of events 4 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/38 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.1%
2/39 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.0%
2/40 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/38 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/39 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.0%
2/40 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.3%
2/38 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.1%
2/39 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • Number of events 3 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.5%
1/40 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/38 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/39 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.0%
2/40 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/38 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/39 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
General disorders
Fatigue
|
7.5%
3/40 • Number of events 3 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
7.5%
3/40 • Number of events 3 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/38 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.1%
2/39 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
5.0%
2/40 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/38 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
2.6%
1/39 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
7.5%
3/40 • Number of events 3 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/38 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/39 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
7.5%
3/40 • Number of events 3 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/38 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/39 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40 • Number of events 2 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/40 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/38 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
0.00%
0/39 • From enrollment until the final study visit, approximately 13 weeks.
Adverse events that started during the wash-out period were assigned to the treatment received during Treatment Period A. Adverse events that started following first dose in Treatment Period B up to end of follow-up were assigned to the treatment received during Treatment Period B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60