Trial Outcomes & Findings for A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD) (NCT NCT01138007)
NCT ID: NCT01138007
Last Updated: 2018-08-10
Results Overview
The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 8/Withdrawal minus the value at Baseline. The least squared means were estimated based on the Analysis of Covariance (ANCOVA) model including Baseline MADRS score and region as covariates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
572 participants
Primary outcome timeframe
Baseline and Week 8/Withdrawal
Results posted on
2018-08-10
Participant Flow
A total of 572 participants were enrolled in the study; however, 3 of these participants were mistakenly registered and were not randomized to study treatment.
Participants who met the inclusion criteria enrolled in the 1- to 2-week Run-in Phase before entering the 8-week Treatment Phase, followed by the 2-week Follow-up Phase. In the Run-in Phase, the previous/existing prohibited medications administered were washed out, and participants' clinical symptoms were carefully monitored.
Participant milestones
| Measure |
Placebo
A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 150 mg
A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
|---|---|---|---|
|
Overall Study
STARTED
|
187
|
190
|
192
|
|
Overall Study
COMPLETED
|
165
|
160
|
144
|
|
Overall Study
NOT COMPLETED
|
22
|
30
|
48
|
Reasons for withdrawal
| Measure |
Placebo
A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 150 mg
A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
12
|
9
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
6
|
|
Overall Study
Protocol Violation
|
2
|
3
|
2
|
|
Overall Study
Protocol-Defined Stopping Criteria
|
6
|
1
|
8
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
5
|
|
Overall Study
Physician Decision
|
0
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
15
|
Baseline Characteristics
A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
Placebo
n=186 Participants
A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 150 mg
n=190 Participants
A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
n=188 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
Total
n=564 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.9 Years
STANDARD_DEVIATION 11.09 • n=93 Participants
|
36.0 Years
STANDARD_DEVIATION 10.42 • n=4 Participants
|
37.5 Years
STANDARD_DEVIATION 10.96 • n=27 Participants
|
37.1 Years
STANDARD_DEVIATION 10.83 • n=483 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
105 Participants
n=27 Participants
|
304 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=93 Participants
|
92 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
260 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
149 participants
n=93 Participants
|
154 participants
n=4 Participants
|
147 participants
n=27 Participants
|
450 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
37 participants
n=93 Participants
|
36 participants
n=4 Participants
|
40 participants
n=27 Participants
|
113 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian - Mixed Race
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
1 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8/WithdrawalPopulation: Full Analysis Set (FAS): all participants who took at least one dose of investigational product and provided at least one efficacy observation at a Treatment Phase visit (i.e. Week 1 or later). Missing values were imputed using Last Observation Carried Forward (LOCF): last observed non-missing value was used to fill missing values at a later point.
The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 8/Withdrawal minus the value at Baseline. The least squared means were estimated based on the Analysis of Covariance (ANCOVA) model including Baseline MADRS score and region as covariates.
Outcome measures
| Measure |
323U66 SR 150 mg
n=190 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
n=188 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
Placebo
n=186 Participants
A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8/Withdrawal
|
-14.4 Scores on a scale
Standard Error 0.77
|
-12.9 Scores on a scale
Standard Error 0.76
|
-13.9 Scores on a scale
Standard Error 0.77
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, and 6Population: FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.
The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 1, 2, 4 and 6 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.
Outcome measures
| Measure |
323U66 SR 150 mg
n=190 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
n=188 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
Placebo
n=186 Participants
A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in the MADRS Total Score at Weeks 1, 2, 4, and 6
Week 6, n=186, 190, 188
|
-11.7 Scores on a scale
Standard Error 0.70
|
-11.1 Scores on a scale
Standard Error 0.69
|
-11.8 Scores on a scale
Standard Error 0.70
|
|
Change From Baseline in the MADRS Total Score at Weeks 1, 2, 4, and 6
Week 1, n=182, 187, 184
|
-2.9 Scores on a scale
Standard Error 0.38
|
-2.7 Scores on a scale
Standard Error 0.38
|
-3.4 Scores on a scale
Standard Error 0.38
|
|
Change From Baseline in the MADRS Total Score at Weeks 1, 2, 4, and 6
Week 2, n=186, 190, 188
|
-5.0 Scores on a scale
Standard Error 0.47
|
-5.0 Scores on a scale
Standard Error 0.47
|
-6.2 Scores on a scale
Standard Error 0.47
|
|
Change From Baseline in the MADRS Total Score at Weeks 1, 2, 4, and 6
Week 4, n=186, 190, 188
|
-8.3 Scores on a scale
Standard Error 0.60
|
-8.2 Scores on a scale
Standard Error 0.60
|
-9.2 Scores on a scale
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline; Week 1, 2, 4, 6, and 8Population: FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.
The MADRS scale measures the depression level of a participant using the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). Scores for MADRS items 1, 2, 6, 7, and 8 were evaluated for this endpoint. Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score of each item and region as covariates.
Outcome measures
| Measure |
323U66 SR 150 mg
n=190 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
n=188 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
Placebo
n=186 Participants
A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 6: Week 8, n=186, 190, 188
|
-1.7 Scores on a scale
Standard Error 0.11
|
-1.6 Scores on a scale
Standard Error 0.11
|
-1.5 Scores on a scale
Standard Error 0.11
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 7: Week 2, n=186, 190, 188
|
-0.6 Scores on a scale
Standard Error 0.09
|
-0.7 Scores on a scale
Standard Error 0.08
|
-0.7 Scores on a scale
Standard Error 0.09
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 7: Week 6, n=186, 190, 188
|
-1.3 Scores on a scale
Standard Error 0.11
|
-1.4 Scores on a scale
Standard Error 0.11
|
-1.4 Scores on a scale
Standard Error 0.11
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 1: Week 1, n=182, 187, 184
|
-0.3 Scores on a scale
Standard Error 0.07
|
-0.3 Scores on a scale
Standard Error 0.07
|
-0.5 Scores on a scale
Standard Error 0.07
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 1: Week 2, n=186, 190, 188
|
-0.5 Scores on a scale
Standard Error 0.08
|
-0.6 Scores on a scale
Standard Error 0.08
|
-0.7 Scores on a scale
Standard Error 0.08
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 1: Week 4, n=186, 190, 188
|
-0.9 Scores on a scale
Standard Error 0.09
|
-1.0 Scores on a scale
Standard Error 0.09
|
-1.0 Scores on a scale
Standard Error 0.09
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 1: Week 6, n=186, 190, 188
|
-1.3 Scores on a scale
Standard Error 0.10
|
-1.3 Scores on a scale
Standard Error 0.10
|
-1.4 Scores on a scale
Standard Error 0.10
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 1: Week 8, n=186, 190, 188
|
-1.6 Scores on a scale
Standard Error 0.10
|
-1.5 Scores on a scale
Standard Error 0.10
|
-1.6 Scores on a scale
Standard Error 0.10
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 2: Week 1, n=182, 187, 184
|
-0.4 Scores on a scale
Standard Error 0.08
|
-0.5 Scores on a scale
Standard Error 0.08
|
-0.5 Scores on a scale
Standard Error 0.08
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 2: Week 2, n=186, 190, 188
|
-0.8 Scores on a scale
Standard Error 0.09
|
-0.7 Scores on a scale
Standard Error 0.09
|
-0.8 Scores on a scale
Standard Error 0.09
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 2: Week 4, n=186, 190, 188
|
-1.2 Scores on a scale
Standard Error 0.10
|
-1.1 Scores on a scale
Standard Error 0.10
|
-1.2 Scores on a scale
Standard Error 0.10
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 2: Week 6, n=186, 190, 188
|
-1.6 Scores on a scale
Standard Error 0.11
|
-1.4 Scores on a scale
Standard Error 0.11
|
-1.6 Scores on a scale
Standard Error 0.11
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 2: Week 8, n=186, 190, 188
|
-2.0 Scores on a scale
Standard Error 0.12
|
-1.7 Scores on a scale
Standard Error 0.12
|
-1.8 Scores on a scale
Standard Error 0.12
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 6: Week 1, n=182, 187, 184
|
-0.4 Scores on a scale
Standard Error 0.07
|
-0.4 Scores on a scale
Standard Error 0.07
|
-0.3 Scores on a scale
Standard Error 0.07
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 6: Week 2, n=186, 190, 188
|
-0.6 Scores on a scale
Standard Error 0.08
|
-0.7 Scores on a scale
Standard Error 0.08
|
-0.6 Scores on a scale
Standard Error 0.08
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 6: Week 4, n=186, 190, 188
|
-1.1 Scores on a scale
Standard Error 0.10
|
-1.0 Scores on a scale
Standard Error 0.09
|
-1.0 Scores on a scale
Standard Error 0.10
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 8: Week 6, n=186, 190, 188
|
-1.2 Scores on a scale
Standard Error 0.11
|
-1.3 Scores on a scale
Standard Error 0.11
|
-1.3 Scores on a scale
Standard Error 0.11
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 6: Week 6, n=186, 190, 188
|
-1.4 Scores on a scale
Standard Error 0.10
|
-1.4 Scores on a scale
Standard Error 0.10
|
-1.3 Scores on a scale
Standard Error 0.10
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 8: Week 8, n=186, 190, 188
|
-1.7 Scores on a scale
Standard Error 0.12
|
-1.5 Scores on a scale
Standard Error 0.11
|
-1.7 Scores on a scale
Standard Error 0.12
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 7: Week 1, n=182, 187, 184
|
-0.3 Scores on a scale
Standard Error 0.08
|
-0.4 Scores on a scale
Standard Error 0.08
|
-0.3 Scores on a scale
Standard Error 0.08
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 7: Week 4, n=186, 190, 188
|
-0.9 Scores on a scale
Standard Error 0.10
|
-1.1 Scores on a scale
Standard Error 0.10
|
-1.0 Scores on a scale
Standard Error 0.10
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 7: Week 8, n=186, 190, 188
|
-1.6 Scores on a scale
Standard Error 0.11
|
-1.6 Scores on a scale
Standard Error 0.11
|
-1.6 Scores on a scale
Standard Error 0.11
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 8: Week 1, n=182, 187, 184
|
-0.3 Scores on a scale
Standard Error 0.08
|
-0.3 Scores on a scale
Standard Error 0.08
|
-0.4 Scores on a scale
Standard Error 0.08
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 8: Week 2, n=186, 190, 188
|
-0.6 Scores on a scale
Standard Error 0.09
|
-0.6 Scores on a scale
Standard Error 0.08
|
-0.8 Scores on a scale
Standard Error 0.09
|
|
Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8
Item 8: Week 4, n=186, 190, 188
|
-0.9 Scores on a scale
Standard Error 0.10
|
-1.0 Scores on a scale
Standard Error 0.10
|
-1.1 Scores on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS. Missing values were imputed using LOCF.
The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS responder is defined as a participant with a \>=50% reduction from Baseline in the MADRS total score at Week 8.
Outcome measures
| Measure |
323U66 SR 150 mg
n=190 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
n=188 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
Placebo
n=186 Participants
A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
|---|---|---|---|
|
Number of MADRS Responders at Week 8
|
98 participants
|
82 participants
|
86 participants
|
SECONDARY outcome
Timeframe: Week 8Population: FAS. Missing values were imputed using LOCF.
The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS remitter is defined as a participant with a MADRS total score \<=11 at Week 8.
Outcome measures
| Measure |
323U66 SR 150 mg
n=190 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
n=188 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
Placebo
n=186 Participants
A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
|---|---|---|---|
|
Number of MADRS Remitters at Week 8
|
60 participants
|
56 participants
|
53 participants
|
SECONDARY outcome
Timeframe: Week 8Population: FAS. Missing values were imputed using LOCF. Only those participants who were available at Week 8 were analyzed.
A CGI-GI assessment was performed at Week 8 (or withdrawal) in comparison with severity in depression observed at Baseline (Week 0; no actual assessment was performed at Baseline \[the comparison was subjective\]), by using scores from 0 to 7: 0, Not assessed; 1, Very much improved; 2, Much improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; 7, Very much worse. A CGI-GI responder is defined as a participant with a CGI-GI score of very much improved or much improved at Week 8.
Outcome measures
| Measure |
323U66 SR 150 mg
n=186 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
n=173 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
Placebo
n=177 Participants
A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
|---|---|---|---|
|
Number of Clinical Global Impression-Global Improvement (CGI-GI) Responders at Week 8
|
103 participants
|
98 participants
|
100 participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 6, and 8Population: FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.
A CGI-SI assessment was performed in terms of severity in depression, by using scores from 0 to 7: 0, Not assessed; 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill participants. Change from Baseline in the CGI-SI score was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline CGI-SI score and region as covariates.
Outcome measures
| Measure |
323U66 SR 150 mg
n=190 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
n=188 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
Placebo
n=186 Participants
A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8
Week 1, n=182, 187, 184
|
-0.1 Scores on a scale
Standard Error 0.03
|
-0.1 Scores on a scale
Standard Error 0.03
|
-0.2 Scores on a scale
Standard Error 0.03
|
|
Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8
Week 8, n=186, 190, 188
|
-1.2 Scores on a scale
Standard Error 0.08
|
-1.1 Scores on a scale
Standard Error 0.08
|
-1.2 Scores on a scale
Standard Error 0.08
|
|
Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8
Week 2, n=186, 190, 188
|
-0.3 Scores on a scale
Standard Error 0.04
|
-0.2 Scores on a scale
Standard Error 0.04
|
-0.3 Scores on a scale
Standard Error 0.04
|
|
Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8
Week 4, n=186, 190, 188
|
-0.5 Scores on a scale
Standard Error 0.06
|
-0.6 Scores on a scale
Standard Error 0.06
|
-0.7 Scores on a scale
Standard Error 0.06
|
|
Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8
Week 6, n=186, 190, 188
|
-0.9 Scores on a scale
Standard Error 0.07
|
-0.9 Scores on a scale
Standard Error 0.07
|
-0.9 Scores on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 6, and 8Population: FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.
The IDS-SR is a 30-item scale used to evaluate the severity and changes in depressive symptoms. Each item was scored from 0 (no symptoms) to 3 (greatest symptom severity). The maximum total score is 84 (0: no symptoms; 84: greatest symptom severity), as participants were asked to answer either item 11 (decreased appetite) or item 12 (increased appetite) (not both) and either item 13 (decreased weight) or item 14 (increased weight) (not both). Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline IDS-SR score and region as covariates.
Outcome measures
| Measure |
323U66 SR 150 mg
n=190 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
n=188 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
Placebo
n=186 Participants
A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8
Week 1, n=182, 187, 184
|
-4.2 Scores on a scale
Standard Error 0.57
|
-3.9 Scores on a scale
Standard Error 0.57
|
-4.8 Scores on a scale
Standard Error 0.57
|
|
Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8
Week 2, n=186, 190, 188
|
-6.7 Scores on a scale
Standard Error 0.68
|
-5.8 Scores on a scale
Standard Error 0.68
|
-6.9 Scores on a scale
Standard Error 0.68
|
|
Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8
Week 4, n=186, 190, 188
|
-9.3 Scores on a scale
Standard Error 0.82
|
-8.2 Scores on a scale
Standard Error 0.81
|
-9.7 Scores on a scale
Standard Error 0.82
|
|
Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8
Week 6, n=186, 190, 188
|
-12.3 Scores on a scale
Standard Error 0.88
|
-10.9 Scores on a scale
Standard Error 0.87
|
-11.5 Scores on a scale
Standard Error 0.88
|
|
Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8
Week 8, n=186, 190, 188
|
-14.5 Scores on a scale
Standard Error 0.95
|
-12.6 Scores on a scale
Standard Error 0.94
|
-13.6 Scores on a scale
Standard Error 0.95
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 6, and 8Population: FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.
The IDS-SR is a 30-item scale used to evaluate the severity and changes in depressive symptoms. Each item was scored from 0 (no symptoms) to 3 (greatest symptom severity). Only five items (item 19: general interest; item 20: energy level; item 21: capacity for pleasure or enjoyment, excluding sex; item 22: interest in sex; item 30: leaden paralysis/physical energy) were evaluated for this endpoint, as a subset of the total score. The lowest possible total score and subset total score of IDS-SR are 0 and 0, and the highest possible total score and subset total score of IDS-SR are 84 and 15, respectively. Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline IDS-SR subscore and region as covariates.
Outcome measures
| Measure |
323U66 SR 150 mg
n=190 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
n=188 Participants
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
Placebo
n=186 Participants
A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8
Week 1, n=182, 187, 184
|
-0.9 Scores on a scale
Standard Error 0.16
|
-0.9 Scores on a scale
Standard Error 0.16
|
-1.1 Scores on a scale
Standard Error 0.16
|
|
Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8
Week 2, n=186, 190, 188
|
-1.2 Scores on a scale
Standard Error 0.18
|
-1.3 Scores on a scale
Standard Error 0.18
|
-1.3 Scores on a scale
Standard Error 0.18
|
|
Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8
Week 4, n=186, 190, 188
|
-1.8 Scores on a scale
Standard Error 0.20
|
-2.0 Scores on a scale
Standard Error 0.20
|
-2.1 Scores on a scale
Standard Error 0.20
|
|
Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8
Week 6, n=186, 190, 188
|
-2.6 Scores on a scale
Standard Error 0.22
|
-2.5 Scores on a scale
Standard Error 0.22
|
-2.5 Scores on a scale
Standard Error 0.22
|
|
Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8
Week 8, n=186, 190, 188
|
-3.1 Scores on a scale
Standard Error 0.24
|
-3.0 Scores on a scale
Standard Error 0.24
|
-2.9 Scores on a scale
Standard Error 0.24
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 63 other events
Deaths: 0 deaths
323U66 SR 150 mg
Serious events: 2 serious events
Other events: 62 other events
Deaths: 0 deaths
323U66 SR 300 mg
Serious events: 1 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=186 participants at risk
A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 150 mg
n=190 participants at risk
A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
n=189 participants at risk
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/186 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
0.00%
0/190 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
0.53%
1/189 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/186 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
0.53%
1/190 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
0.00%
0/189 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.54%
1/186 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
0.00%
0/190 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
0.00%
0/189 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
|
Nervous system disorders
Headache
|
0.00%
0/186 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
0.53%
1/190 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
0.00%
0/189 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
|
Psychiatric disorders
Depression
|
0.54%
1/186 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
0.00%
0/190 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
0.00%
0/189 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
Other adverse events
| Measure |
Placebo
n=186 participants at risk
A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 150 mg
n=190 participants at risk
A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
|
323U66 SR 300 mg
n=189 participants at risk
A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
18.8%
35/186 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
13.7%
26/190 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
15.3%
29/189 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
8/186 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
6.3%
12/190 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
14.8%
28/189 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
|
Nervous system disorders
Headache
|
7.0%
13/186 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
7.9%
15/190 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
10.1%
19/189 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
8.1%
15/186 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
6.8%
13/190 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
8.5%
16/189 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
3/186 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
4.2%
8/190 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
5.8%
11/189 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
|
Psychiatric disorders
Insomnia
|
3.2%
6/186 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
0.00%
0/190 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
5.3%
10/189 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of investigational product until the completion of the Follow-up Phase (up to 12 weeks from the start of the Run-in Phase).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who took at least one dose of investigational product.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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