Trial Outcomes & Findings for A Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Orvepitant in Subjects With Major Depressive Disorder (NCT NCT00880048)
NCT ID: NCT00880048
Last Updated: 2017-10-13
Results Overview
HAM-D was use to measure the severity of depressive symptoms in participants with primary depressive illness. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. Items with quantifiable severity were scored 0 (lowest severity) to 4 (greatest severity); The HAM-D total score was calculated by summing the individual response scores. The lowest possible score was 0 (absence of depression) and the highest possible score was 52 (most severe measure of depression). For the last observation carried forward analyses, the most recent post randomization total score (as opposed to individual responses) was "carried forward" and used in the calculation of the change from randomization (Baseline) value. If the responses to more than 1 question were missing for a participant at a particular time point, the total score was not calculated. Change from Baseline in total score was the difference between HAM-D total score at the time point being analyzed and randomization.
TERMINATED
PHASE2
343 participants
Baseline and up to Week 6
2017-10-13
Participant Flow
The study was conducted at 31 centers across the North America (27 centers in United States of America and 4 centers in Canada) during the period 06 April 2009 to 21 June 2010. Total of 1604 participants were screened for study eligibility, of which 343 participants were randomized into the study.
A total of 339 participants were included in Intent-to-treat (ITT) population. ITT population comprised of all participants who gave informed consent, were randomized, received at least one dose of double blind medication and for whom at least one post-randomization assessment was available.
Participant milestones
| Measure |
Placebo
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
116
|
115
|
112
|
|
Overall Study
COMPLETED
|
88
|
82
|
77
|
|
Overall Study
NOT COMPLETED
|
28
|
33
|
35
|
Reasons for withdrawal
| Measure |
Placebo
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
5
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
2
|
|
Overall Study
Protocol Violation
|
4
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
5
|
|
Overall Study
Physician Decision
|
1
|
1
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
5
|
|
Overall Study
Study closed/terminated
|
9
|
7
|
6
|
Baseline Characteristics
A Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Orvepitant in Subjects With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=115 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
Total
n=343 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.7 Years
STANDARD_DEVIATION 10.61 • n=5 Participants
|
40.4 Years
STANDARD_DEVIATION 11.35 • n=7 Participants
|
43.1 Years
STANDARD_DEVIATION 10.66 • n=5 Participants
|
41.7 Years
STANDARD_DEVIATION 10.90 • n=4 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
237 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to Week 6Population: ITT Population. Only those participants available at the specified time points were analyzed.
HAM-D was use to measure the severity of depressive symptoms in participants with primary depressive illness. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. Items with quantifiable severity were scored 0 (lowest severity) to 4 (greatest severity); The HAM-D total score was calculated by summing the individual response scores. The lowest possible score was 0 (absence of depression) and the highest possible score was 52 (most severe measure of depression). For the last observation carried forward analyses, the most recent post randomization total score (as opposed to individual responses) was "carried forward" and used in the calculation of the change from randomization (Baseline) value. If the responses to more than 1 question were missing for a participant at a particular time point, the total score was not calculated. Change from Baseline in total score was the difference between HAM-D total score at the time point being analyzed and randomization.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score
Week 1
|
-2.85 Scores on a scale
Standard Error 0.454
|
-4.45 Scores on a scale
Standard Error 0.462
|
-5.11 Scores on a scale
Standard Error 0.470
|
|
Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score
Week 6
|
-8.29 Scores on a scale
Standard Error 0.727
|
-9.95 Scores on a scale
Standard Error 0.754
|
-9.05 Scores on a scale
Standard Error 0.777
|
|
Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score
Week 2
|
-4.35 Scores on a scale
Standard Error 0.531
|
-5.92 Scores on a scale
Standard Error 0.545
|
-6.00 Scores on a scale
Standard Error 0.565
|
|
Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score
Week 4
|
-6.87 Scores on a scale
Standard Error 0.672
|
-8.68 Scores on a scale
Standard Error 0.691
|
-8.90 Scores on a scale
Standard Error 0.703
|
SECONDARY outcome
Timeframe: Up to Week 6Population: ITT Population. Only those participants available at the specified time points were analyzed.
HAM-D was use to measure the severity of depressive symptoms in participants with primary depressive illness. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The HAM-D Total Score was calculated by summing the individual response scores. The lowest possible score was 0 (absence of depression) and the highest possible score was 52 (most severe measure of depression). For the last observation carried forward analyses, the most recent post randomization total score (as opposed to individual responses) was "carried forward" and used in the calculation of the change from randomization value. If the responses to more than 1 question were missing for a participant at a particular time point, the total score was not calculated. Data was presented as percent of HAM-D responders which was defined as participants who has a \>=50% reduction from randomization in HAM-D total score.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Percentage of Participants With a >=50% Reduction From Baseline in HAM-D Total Score
Week 2
|
9 Percentage of participants
|
14 Percentage of participants
|
13 Percentage of participants
|
|
Percentage of Participants With a >=50% Reduction From Baseline in HAM-D Total Score
Week 6
|
27 Percentage of participants
|
37 Percentage of participants
|
30 Percentage of participants
|
|
Percentage of Participants With a >=50% Reduction From Baseline in HAM-D Total Score
Week 1
|
4 Percentage of participants
|
7 Percentage of participants
|
10 Percentage of participants
|
|
Percentage of Participants With a >=50% Reduction From Baseline in HAM-D Total Score
Week 4
|
22 Percentage of participants
|
27 Percentage of participants
|
29 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 6Population: ITT Population.
The start of the 'maintained antidepressant response' was the time at which a participant demonstrates a 50% reduction from randomization in their HAM-D total score and where this response was maintained until the end of the treatment phase (week 6). Participants who met the 50% reduction at week 6 without having met it at week 4 were considered to have reached a maintained response, and therefore were censored at week 6. Where a participant met the criteria for maintained antidepressant response, the "time (in days) to maintained antidepressant response" was calculated as: (Date of assessment at which the maintained response commences minus Date of randomization) plus 1. Where a participant did not met the criteria for maintained antidepressant response, their time to response was censored at the last on-treatment assessment they undertake, up to and including the week 6 assessment.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Number of Participants Who Maintained Clinical Response by Week 6
|
14 Participants
|
20 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 6Population: ITT Population. Only those participants available at the specified time points were analyzed.
The BECH scale was extracted from the HAMD-17 and comprised the 6 items (sum of items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D scale): Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic and Somatic Symptoms General. The BECH Total Score was calculated by summing the individual response scores. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The lowest possible score was 0 (absence of depression) and the highest possible score was 22 (most severe measure of depression). Due to the small number of items , missing data was not imputed for the BECH Total Score. If any of the 6 items above were missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in BECH Total Score was the difference between BECH Total Score at the time point being analyzed to randomization.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D Scale)
Week 2
|
-2.17 Scores on a scale
Standard Error 0.287
|
-2.64 Scores on a scale
Standard Error 0.296
|
-2.79 Scores on a scale
Standard Error 0.307
|
|
Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D Scale)
Week 1
|
-1.24 Scores on a scale
Standard Error 0.233
|
-1.94 Scores on a scale
Standard Error 0.237
|
-2.05 Scores on a scale
Standard Error 0.241
|
|
Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D Scale)
Week 4
|
-3.34 Scores on a scale
Standard Error 0.357
|
-4.01 Scores on a scale
Standard Error 0.368
|
-4.09 Scores on a scale
Standard Error 0.374
|
|
Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D Scale)
Week 6
|
-3.69 Scores on a scale
Standard Error 0.394
|
-4.78 Scores on a scale
Standard Error 0.409
|
-4.21 Scores on a scale
Standard Error 0.421
|
SECONDARY outcome
Timeframe: Baseline and up to Week 6Population: ITT Population. Only those participants available at the specified time points were analyzed.
QIDS-SR assessed symptoms severity of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criterion for major depressive disorder. It consisted of 16 separate items, defining 9 DSM-IV symptom criterion domains. A total score was obtained by summing scores on each domain. The lowest possible score was 0, which represented an absence of depression; the highest possible score was 27, which represented the most severe measure of depression. Due to the small number of items, missing data was not imputed for the QIDS-SR total score. If any of the 9 domains above were missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in total score was the difference between QIDS total score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score
Week 2
|
-3.64 Scores on a scale
Standard Error 0.445
|
-5.08 Scores on a scale
Standard Error 0.455
|
-5.48 Scores on a scale
Standard Error 0.473
|
|
Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score
Week 1
|
-2.14 Scores on a scale
Standard Error 0.386
|
-3.17 Scores on a scale
Standard Error 0.395
|
-4.41 Scores on a scale
Standard Error 0.399
|
|
Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score
Week 4
|
-5.20 Scores on a scale
Standard Error 0.498
|
-6.78 Scores on a scale
Standard Error 0.510
|
-7.06 Scores on a scale
Standard Error 0.523
|
|
Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score
Week 6
|
-6.17 Scores on a scale
Standard Error 0.543
|
-7.70 Scores on a scale
Standard Error 0.562
|
-7.58 Scores on a scale
Standard Error 0.588
|
SECONDARY outcome
Timeframe: Baseline and up to Week 6Population: ITT Population. Only those participants available at the specified time points were analyzed.
The anxiety score was extracted from the HAM-D-17 and comprises of items 10, 11, 12, 13 and 15 from the HAM-D scale. The anxiety score was calculated by summing the individual response scores to these questions. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The lowest possible score was 0 (absence of depression) and the highest possible score was 18 (most severe measure of depression). Due to the small number of items, missing data was not imputed for the anxiety score. If either of the anxiety items was missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in anxiety score was the difference between the anxiety score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17)
Week 1
|
-0.81 Scores on a scale
Standard Error 0.169
|
-1.09 Scores on a scale
Standard Error 0.172
|
-1.57 Scores on a scale
Standard Error 0.175
|
|
Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17)
Week 2
|
-1.40 Scores on a scale
Standard Error 0.185
|
-1.55 Scores on a scale
Standard Error 0.189
|
-1.73 Scores on a scale
Standard Error 0.197
|
|
Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17)
Week 4
|
-1.96 Scores on a scale
Standard Error 0.233
|
-2.31 Scores on a scale
Standard Error 0.239
|
-2.63 Scores on a scale
Standard Error 0.243
|
|
Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17)
Week 6
|
-2.37 Scores on a scale
Standard Error 0.235
|
-2.70 Scores on a scale
Standard Error 0.244
|
-2.56 Scores on a scale
Standard Error 0.254
|
SECONDARY outcome
Timeframe: Up to Week 6Population: ITT Population. Only those participants available at the specified time points were analyzed.
The CGI-I assessed scores range from 1 - Very much Improved to 7 - Very much worse, with 0 representing a participant that was not assessed. The assessed scores were dichotomized. Scores of 1 or 2 was in the first category, scoring 1. All other scores (except zero which was regarded as missing) was in the second category, scoring 0. The percentage of participants in the first category was calculated for each assessment.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score
Week 1
|
4 Percentage of participants
|
12 Percentage of participants
|
9 Percentage of participants
|
|
Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score
Week 6
|
35 Percentage of participants
|
44 Percentage of participants
|
42 Percentage of participants
|
|
Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score
Week 2
|
10 Percentage of participants
|
25 Percentage of participants
|
18 Percentage of participants
|
|
Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score
Week 4
|
33 Percentage of participants
|
36 Percentage of participants
|
39 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 6Population: ITT Population. Only those participants available at the specified time points were analyzed.
The CGI-S assessed scores range from 1 - Very much Improved to 7 - Very much worse, with 0 representing a participant that was not assessed. For the CGI-S, remote, blinded MedAvante, raters assessed the participant's severity of illness considering their total clinical experience with the particular population being studied and information obtained during the Baseline HAMD interview with the participant. Value at randomization was the Baseline value. Change from Baseline in total score was the difference between CGI-S Score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score
Week 1
|
-0.42 Scores on a scale
Standard Error 0.075
|
-0.57 Scores on a scale
Standard Error 0.076
|
-0.69 Scores on a scale
Standard Error 0.077
|
|
Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score
Week 2
|
-0.58 Scores on a scale
Standard Error 0.093
|
-0.83 Scores on a scale
Standard Error 0.095
|
-0.78 Scores on a scale
Standard Error 0.099
|
|
Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score
Week 4
|
-0.98 Scores on a scale
Standard Error 0.111
|
-1.25 Scores on a scale
Standard Error 0.114
|
-1.26 Scores on a scale
Standard Error 0.116
|
|
Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score
Week 6
|
-1.07 Scores on a scale
Standard Error 0.123
|
-1.45 Scores on a scale
Standard Error 0.127
|
-1.27 Scores on a scale
Standard Error 0.132
|
SECONDARY outcome
Timeframe: Baseline and up to Week 6Population: ITT Population. Only those participants available at the specified time points were analyzed.
CPFQ was a brief self-report scale which was designed to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ comprised of 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question was rated on a scale of 1 to 6, with 1 indicating greater than normal functioning, 2, indicating normal functioning, and with higher numbers indicating poorer functioning. Two versions of the CPFQ were utilized during the study. The Baseline CPFQ requested the participant reflect back over the past month. For the treatment period, the CPFQ requested the participant reflect back over the past week. Value at randomization was the Baseline value. Change from Baseline in Total Score was the difference between CPFQ Score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score
Week 4
|
-5.91 Scores on a scale
Standard Error 0.631
|
-6.68 Scores on a scale
Standard Error 0.652
|
-6.64 Scores on a scale
Standard Error 0.670
|
|
Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score
Week 6
|
-6.34 Scores on a scale
Standard Error 0.688
|
-7.28 Scores on a scale
Standard Error 0.717
|
-7.53 Scores on a scale
Standard Error 0.746
|
|
Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score
Week 1
|
-2.56 Scores on a scale
Standard Error 0.543
|
-4.13 Scores on a scale
Standard Error 0.551
|
-3.30 Scores on a scale
Standard Error 0.560
|
|
Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score
Week 2
|
-3.43 Scores on a scale
Standard Error 0.588
|
-4.83 Scores on a scale
Standard Error 0.605
|
-5.37 Scores on a scale
Standard Error 0.625
|
SECONDARY outcome
Timeframe: Baseline and up to Week 6Population: ITT Population. Only those participants available at the specified time points were analyzed.
The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Week 1, total sleep time
|
20.79 minutes (min)
Standard Error 9.733
|
43.31 minutes (min)
Standard Error 9.800
|
54.00 minutes (min)
Standard Error 10.056
|
|
Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Week 2, total sleep time
|
34.02 minutes (min)
Standard Error 9.635
|
41.64 minutes (min)
Standard Error 9.743
|
55.42 minutes (min)
Standard Error 10.128
|
|
Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Week 6, total sleep time
|
52.03 minutes (min)
Standard Error 9.986
|
54.21 minutes (min)
Standard Error 10.394
|
80.43 minutes (min)
Standard Error 10.956
|
|
Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Week 2, sleep onset latency
|
-21.70 minutes (min)
Standard Error 7.417
|
-34.15 minutes (min)
Standard Error 7.508
|
-19.95 minutes (min)
Standard Error 7.815
|
|
Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Week 6, wake time after sleep onset
|
1.34 minutes (min)
Standard Error 6.926
|
-13.17 minutes (min)
Standard Error 7.479
|
-15.76 minutes (min)
Standard Error 7.932
|
|
Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Week 4, total sleep time
|
33.07 minutes (min)
Standard Error 10.144
|
63.94 minutes (min)
Standard Error 10.463
|
69.59 minutes (min)
Standard Error 10.641
|
|
Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Week 1, sleep onset latency
|
-12.50 minutes (min)
Standard Error 6.310
|
-36.40 minutes (min)
Standard Error 6.372
|
-37.99 minutes (min)
Standard Error 6.547
|
|
Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Week 4, sleep onset latency
|
-27.84 minutes (min)
Standard Error 6.940
|
-40.76 minutes (min)
Standard Error 7.143
|
-38.39 minutes (min)
Standard Error 7.290
|
|
Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Week 6, sleep onset latency
|
-18.93 minutes (min)
Standard Error 8.284
|
-47.51 minutes (min)
Standard Error 8.684
|
-48.99 minutes (min)
Standard Error 9.163
|
|
Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Week 1, wake time after sleep onset
|
4.61 minutes (min)
Standard Error 4.661
|
-12.58 minutes (min)
Standard Error 4.807
|
-11.54 minutes (min)
Standard Error 5.061
|
|
Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Week 2, wake time after sleep onset
|
-8.10 minutes (min)
Standard Error 5.652
|
-6.21 minutes (min)
Standard Error 6.061
|
-2.83 minutes (min)
Standard Error 6.298
|
|
Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Week 4, wake time after sleep onset
|
-7.36 minutes (min)
Standard Error 5.087
|
-9.86 minutes (min)
Standard Error 5.505
|
-16.80 minutes (min)
Standard Error 5.670
|
SECONDARY outcome
Timeframe: Baseline and upto Week 6Population: ITT Population. Only those participants available at the specified time points were analyzed.
The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the MSQ Number of Nocturnal Awakenings
Week 1
|
-0.06 Number of awakenings
Standard Error 0.130
|
-0.63 Number of awakenings
Standard Error 0.134
|
-0.16 Number of awakenings
Standard Error 0.141
|
|
Change From Baseline in the MSQ Number of Nocturnal Awakenings
Week 2
|
-0.52 Number of awakenings
Standard Error 0.116
|
-0.77 Number of awakenings
Standard Error 0.124
|
-0.47 Number of awakenings
Standard Error 0.130
|
|
Change From Baseline in the MSQ Number of Nocturnal Awakenings
Week 4
|
-0.38 Number of awakenings
Standard Error 0.174
|
-0.43 Number of awakenings
Standard Error 0.187
|
-0.78 Number of awakenings
Standard Error 0.194
|
|
Change From Baseline in the MSQ Number of Nocturnal Awakenings
Week 6
|
-0.63 Number of awakenings
Standard Error 0.152
|
-0.42 Number of awakenings
Standard Error 0.165
|
-0.87 Number of awakenings
Standard Error 0.175
|
SECONDARY outcome
Timeframe: Baseline and up to Week 6Population: ITT Population. Only those participants available at the specified time points were analyzed.
The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep
Week 2, sleep quality
|
1.03 Scores on a scale
Standard Error 0.204
|
1.46 Scores on a scale
Standard Error 0.206
|
1.54 Scores on a scale
Standard Error 0.214
|
|
Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep
Week 4, sleep quality
|
1.39 Scores on a scale
Standard Error 0.212
|
2.12 Scores on a scale
Standard Error 0.219
|
1.82 Scores on a scale
Standard Error 0.222
|
|
Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep
Week 1, refreshing value of sleep
|
0.97 Scores on a scale
Standard Error 0.193
|
1.31 Scores on a scale
Standard Error 0.195
|
1.60 Scores on a scale
Standard Error 0.200
|
|
Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep
Week 4, refreshing value of sleep
|
1.61 Scores on a scale
Standard Error 0.216
|
2.30 Scores on a scale
Standard Error 0.223
|
2.00 Scores on a scale
Standard Error 0.227
|
|
Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep
Week 1, sleep quality
|
0.73 Scores on a scale
Standard Error 0.196
|
1.32 Scores on a scale
Standard Error 0.198
|
1.45 Scores on a scale
Standard Error 0.203
|
|
Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep
Week 6, sleep quality
|
1.77 Scores on a scale
Standard Error 0.234
|
2.34 Scores on a scale
Standard Error 0.243
|
2.09 Scores on a scale
Standard Error 0.254
|
|
Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep
Week 2, refreshing value of sleep
|
1.15 Scores on a scale
Standard Error 0.201
|
1.48 Scores on a scale
Standard Error 0.203
|
1.80 Scores on a scale
Standard Error 0.211
|
|
Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep
Week 6, refreshing value of sleep
|
1.86 Scores on a scale
Standard Error 0.242
|
2.23 Scores on a scale
Standard Error 0.252
|
2.57 Scores on a scale
Standard Error 0.264
|
SECONDARY outcome
Timeframe: Up to Week 6Population: ITT Population. Only those participants available at the specified time points were analyzed.
A HAMD remitter was defined as a participant who had a HAMD Total Score \<=7. The HAMD total score was calculated for each participant at each time point. Those participants with no missing value for HAMD total score were categorized as having a HAMD total score of \<=7 or \>7.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Number of HAM-D Remitters
Week 1
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of HAM-D Remitters
Week 2
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of HAM-D Remitters
Week 4
|
6 Participants
|
13 Participants
|
14 Participants
|
|
Number of HAM-D Remitters
Week 6
|
10 Participants
|
19 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 17 days post-treatmentPopulation: The All Subjects Population was defined as all participants who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.
Assessment of suicidality were done through use of the CSSRS for suicidal ideation and suicidal behavior. For suicidal ideation ratings were 1 to 5, where 1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation without intent to act, 4. Active suicidal ideation with any methods (not plan) without intent to act, 5. Active suicidal ideation with specific plan and intent and for suicidal behavior ratings were 6 to 12, Where 6. Actual attempt, 7. Engaged in non-suicidal self-injurious behavior, 8. Interrupted attempt, 9. Aborted attempt, 10. Preparatory acts or behavior, 11. Suicidal behavior, 12. Completed suicide. n= number participants with at least one CSSRS assessment after the first dose of study medication (i.e. on treatment or post treatment). Only those categories from CSSRS (1-12) are presented for which symptoms were actually observed in the participants. Categories with null values for all the arms have not been presented.
Outcome measures
| Measure |
Placebo
n=115 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=111 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Number of Participants With Suicide-Related Events Based on the Columbia Suicidality Severity Rating Scale (CSSRS)
Wish to be dead
|
46 Participants
|
41 Participants
|
36 Participants
|
|
Number of Participants With Suicide-Related Events Based on the Columbia Suicidality Severity Rating Scale (CSSRS)
Non-specific active suicidal thoughts
|
12 Participants
|
12 Participants
|
11 Participants
|
|
Number of Participants With Suicide-Related Events Based on the Columbia Suicidality Severity Rating Scale (CSSRS)
Active SI without intent to act (ITA)
|
8 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants With Suicide-Related Events Based on the Columbia Suicidality Severity Rating Scale (CSSRS)
Active SI with any methods (not plan) without ITA
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Suicide-Related Events Based on the Columbia Suicidality Severity Rating Scale (CSSRS)
Active SI with specific plan and intent
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Suicide-Related Events Based on the Columbia Suicidality Severity Rating Scale (CSSRS)
Engaged in non-suicidal self-injurious behavior
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 17 days post-treatmentPopulation: All subjects Population. Only those participants available at the specified time points were analyzed.
The DESS scale consisted of 43 signs and symptoms, scored as 'new symptom', 'old symptom but worse', 'old symptom but improved' or 'symptom not present/old symptom but unchanged'. The total number of new signs and symptoms, old symptoms but worse, old symptoms but improved and the total number of new or old-but-worse signs and symptoms were calculated for each treatment and visit. n = number of subjects who had at least one of the 43 symptoms in the specified category. The summary for a specified category are of the number of symptoms the n subjects had in that category. Treatment period was up to Week 6.
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=115 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=112 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Number of Incidences of Discontinuation Emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)
New Symptom
|
—
|
6.0 Number of Incidences
Standard Deviation 5.66
|
2.7 Number of Incidences
Standard Deviation 1.53
|
|
Number of Incidences of Discontinuation Emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)
Old Symptom But Improved
|
1.0 Number of Incidences
Standard Deviation NA
Only one participant was analyzed
|
5.0 Number of Incidences
Standard Deviation 5.66
|
3.0 Number of Incidences
Standard Deviation 1.41
|
|
Number of Incidences of Discontinuation Emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)
Unchanged/ Not present
|
42.7 Number of Incidences
Standard Deviation 0.58
|
33.8 Number of Incidences
Standard Deviation 6.60
|
39.6 Number of Incidences
Standard Deviation 5.34
|
|
Number of Incidences of Discontinuation Emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)
Old Symptom But Worsened
|
—
|
7.5 Number of Incidences
Standard Deviation 0.71
|
4.3 Number of Incidences
Standard Deviation 3.77
|
|
Number of Incidences of Discontinuation Emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)
New or Old but Worsened
|
—
|
9.0 Number of Incidences
Standard Deviation 7.55
|
5.0 Number of Incidences
Standard Deviation 4.30
|
SECONDARY outcome
Timeframe: Baseline and up to Week 6Population: All subjects Population (males). Only those participants available at the specified time points were analyzed.
MSFQ included five items with a score ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 5 = markedly diminished; and 6 = totally absent). The following areas of sexual functioning were included: diminished/absent libido; arousal difficulties; orgasm difficulties/anorgasmia; erectile dysfunction (males only) and degree of sexual satisfaction. A total score was used as a global measure of sexual dysfunction. The Baseline MSFQ requested the participant reflect back over the past month. For the treatment period, the follow-up MSFQ requested the participant reflect back over the past week. Change from Baseline was the value at post-Baseline visit minus Baseline value.
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=40 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=39 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ) Total Score in Males
Week 2
|
-3.44 Scores on a scale
Standard Error 0.840
|
-1.00 Scores on a scale
Standard Error 0.968
|
-2.53 Scores on a scale
Standard Error 0.988
|
|
Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ) Total Score in Males
Week 1
|
-1.88 Scores on a scale
Standard Error 0.690
|
-0.84 Scores on a scale
Standard Error 0.787
|
-2.43 Scores on a scale
Standard Error 0.795
|
|
Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ) Total Score in Males
Week 4
|
-3.88 Scores on a scale
Standard Error 1.003
|
-3.70 Scores on a scale
Standard Error 1.122
|
-4.59 Scores on a scale
Standard Error 1.141
|
|
Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ) Total Score in Males
Week 6
|
-3.79 Scores on a scale
Standard Error 1.136
|
-4.47 Scores on a scale
Standard Error 1.269
|
-4.46 Scores on a scale
Standard Error 1.322
|
SECONDARY outcome
Timeframe: Baseline and up to Week 6Population: All Subject Population (female). Only those participants available at the specified time points were analyzed.
MSFQ included five items with a score ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 5 = markedly diminished; and 6 = totally absent). The following areas of sexual functioning were included: diminished/absent libido; arousal difficulties; orgasm difficulties/anorgasmia; erectile dysfunction (males only) and degree of sexual satisfaction. A total score was used as a global measure of sexual dysfunction. The Baseline MSFQ requested the participant reflect back over the past month. For the treatment period, the follow-up MSFQ requested the participant reflect back over the past week. Change from Baseline was the value at post-Baseline visit minus Baseline value.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=75 Participants
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=73 Participants
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in the MSFQ Total Score in Females
Week 2
|
-0.62 scores on a scale
Standard Error 0.577
|
-1.38 scores on a scale
Standard Error 0.578
|
0.32 scores on a scale
Standard Error 0.578
|
|
Change From Baseline in the MSFQ Total Score in Females
Week 1
|
0.15 scores on a scale
Standard Error 0.473
|
-0.82 scores on a scale
Standard Error 0.473
|
0.62 scores on a scale
Standard Error 0.467
|
|
Change From Baseline in the MSFQ Total Score in Females
Week 4
|
-1.64 scores on a scale
Standard Error 0.645
|
-2.62 scores on a scale
Standard Error 0.653
|
-1.58 scores on a scale
Standard Error 0.645
|
|
Change From Baseline in the MSFQ Total Score in Females
Week 6
|
-2.39 scores on a scale
Standard Error 0.699
|
-2.94 scores on a scale
Standard Error 0.718
|
-1.68 scores on a scale
Standard Error 0.724
|
Adverse Events
Placebo
GW823296 30 mg
GW823296 60 mg
Serious adverse events
| Measure |
Placebo
n=116 participants at risk
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=115 participants at risk
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=112 participants at risk
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Convulsion
|
0.00%
0/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
0.00%
0/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
1.8%
2/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
0.87%
1/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
0.00%
0/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.86%
1/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
0.00%
0/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
0.00%
0/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
0.00%
0/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
0.89%
1/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=116 participants at risk
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
|
GW823296 30 mg
n=115 participants at risk
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
|
GW823296 60 mg
n=112 participants at risk
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
12.1%
14/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
9.6%
11/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
10.7%
12/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
13.8%
16/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
7.0%
8/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
8.9%
10/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.9%
8/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
10.4%
12/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
8.9%
10/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
5/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
2.6%
3/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
5.4%
6/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
5.2%
6/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
3.5%
4/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
3.6%
4/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
2/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
3.5%
4/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
6.2%
7/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
16.4%
19/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
16.5%
19/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
21.4%
24/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
5.2%
6/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
10.4%
12/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
7.1%
8/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
3.4%
4/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
7.8%
9/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
7.1%
8/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
1.7%
2/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
3.5%
4/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
8.0%
9/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
1.7%
2/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
5.2%
6/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
4.5%
5/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
General disorders
Fatigue
|
1.7%
2/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
7.8%
9/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
6.2%
7/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
4/116 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
6.1%
7/115 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
6.2%
7/112 • AEs were reported up to follow up (28 day) post-treatment (Week 6)
AEs were reported for the All subjects Population which was defined as all participants who received at least one dose of study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER