Trial Outcomes & Findings for Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study) (NCT NCT00866294)
NCT ID: NCT00866294
Last Updated: 2017-01-30
Results Overview
The HAM-D measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at Week 8 minus the Baseline value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
416 participants
Primary outcome timeframe
Baseline (Week 0) and Week 8
Results posted on
2017-01-30
Participant Flow
Participants who had completed all the study procedures (up to the post-study examinations) were defined as per protocol completers.
Participant milestones
| Measure |
Placebo
Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
|
Paroxetine CR
An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
|
Paroxetine IR
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
172
|
161
|
83
|
|
Overall Study
COMPLETED
|
139
|
141
|
72
|
|
Overall Study
NOT COMPLETED
|
33
|
20
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
|
Paroxetine CR
An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
|
Paroxetine IR
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
12
|
13
|
9
|
|
Overall Study
Lack of Efficacy
|
7
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
|
Overall Study
Met Protocol-defined Stopping Criteria
|
5
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
|
Overall Study
Physician Decision
|
6
|
2
|
1
|
Baseline Characteristics
Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)
Baseline characteristics by cohort
| Measure |
Placebo
n=172 Participants
Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
|
Paroxetine CR
n=161 Participants
An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
|
Paroxetine IR
n=83 Participants
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
|
Total
n=416 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.8 Years
STANDARD_DEVIATION 10.04 • n=93 Participants
|
36.4 Years
STANDARD_DEVIATION 11.36 • n=4 Participants
|
35.5 Years
STANDARD_DEVIATION 10.38 • n=27 Participants
|
36.4 Years
STANDARD_DEVIATION 10.62 • n=483 Participants
|
|
Gender
Female
|
94 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
228 Participants
n=483 Participants
|
|
Gender
Male
|
78 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
188 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
17 participants
n=93 Participants
|
20 participants
n=4 Participants
|
10 participants
n=27 Participants
|
47 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
154 participants
n=93 Participants
|
138 participants
n=4 Participants
|
73 participants
n=27 Participants
|
365 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Week 8Population: Full Analysis Set (FAS): all participants who entered the treatment phase (8 weeks), excluding those who had taken no dose of the investigational product for the treatment phase and who had no data on the HAM-D total score after the start of the treatment phase. The analysis was performed on the last observation carried forward (LOCF) dataset.
The HAM-D measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at Week 8 minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily.
|
Paroxetine CR
n=158 Participants
An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
|
Paroxetine IR
n=83 Participants
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8
|
-10.4 scores on a scale
Standard Error 0.62
|
-12.8 scores on a scale
Standard Error 0.61
|
-12.5 scores on a scale
Standard Error 0.78
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8Population: FAS. The analysis was performed on the following datasets: the observed case (OC) dataset for Week 1 and the LOCF dataset for Weeks 2, 3, 4, 6, and 8, where missing values were imputed by the last observed value in the longitudinal data. One participant in the Paroxetine CR group was not included in the OC analysis for having a missing value.
The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at each time point minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily.
|
Paroxetine CR
n=158 Participants
An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
|
Paroxetine IR
n=83 Participants
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
|
|---|---|---|---|
|
Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8
Week 1, n=171, 157, 83
|
-3.1 scores on a scale
Standard Deviation 4.04
|
-2.9 scores on a scale
Standard Deviation 4.05
|
-3.5 scores on a scale
Standard Deviation 4.36
|
|
Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8
Week 2, n=171, 158, 83
|
-5.2 scores on a scale
Standard Deviation 5.11
|
-5.5 scores on a scale
Standard Deviation 4.85
|
-6.2 scores on a scale
Standard Deviation 4.93
|
|
Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8
Week 3, n=171, 158, 83
|
-6.7 scores on a scale
Standard Deviation 6.05
|
-7.5 scores on a scale
Standard Deviation 5.64
|
-7.3 scores on a scale
Standard Deviation 4.70
|
|
Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8
Week 4, n=171, 158, 83
|
-8.0 scores on a scale
Standard Deviation 6.10
|
-9.3 scores on a scale
Standard Deviation 5.66
|
-9.1 scores on a scale
Standard Deviation 5.66
|
|
Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8
Week 6, n=171, 158, 83
|
-8.8 scores on a scale
Standard Deviation 6.40
|
-10.9 scores on a scale
Standard Deviation 6.21
|
-10.4 scores on a scale
Standard Deviation 5.78
|
|
Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8
Week 8, n=171, 158, 83
|
-9.8 scores on a scale
Standard Deviation 6.68
|
-12.4 scores on a scale
Standard Deviation 6.41
|
-12.0 scores on a scale
Standard Deviation 5.83
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they were withdrawn prematurely.
The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is a sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Responders are defined as participants with a 50 percent or greater reduction from baseline in the HAM-D total score.
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily.
|
Paroxetine CR
n=158 Participants
An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
|
Paroxetine IR
n=83 Participants
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
|
|---|---|---|---|
|
Percentage of HAM-D Responders at Weeks 4 and 8
Week 4, n=158, 154, 78
|
30 percentage of responders
|
40 percentage of responders
|
40 percentage of responders
|
|
Percentage of HAM-D Responders at Weeks 4 and 8
Week 8 (OC), n=144, 145, 74
|
52 percentage of responders
|
66 percentage of responders
|
59 percentage of responders
|
|
Percentage of HAM-D Responders at Weeks 4 and 8
Week 8 LOCF, n=171, 158, 83
|
46 percentage of responders
|
63 percentage of responders
|
57 percentage of responders
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they were withdrawn prematurely.
The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Remitters are defined as participants with a HAM-D total score of 7 or less.
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily.
|
Paroxetine CR
n=158 Participants
An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
|
Paroxetine IR
n=83 Participants
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
|
|---|---|---|---|
|
Percentage of HAM-D Remitters at Weeks 4 and 8
Week 4, n=158, 154, 78
|
16 percentage of remitters
|
15 percentage of remitters
|
18 percentage of remitters
|
|
Percentage of HAM-D Remitters at Weeks 4 and 8
Week 8 (OC), n=144, 145, 74
|
26 percentage of remitters
|
38 percentage of remitters
|
39 percentage of remitters
|
|
Percentage of HAM-D Remitters at Weeks 4 and 8
Week 8 LOCF, n=171, 158, 83
|
23 percentage of remitters
|
35 percentage of remitters
|
36 percentage of remitters
|
SECONDARY outcome
Timeframe: Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8Population: FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they had missing values or they were withdrawn prematurely.
The 7-point CGI-SI scale assesses the clinician's impression of the participant's current illness state. Scores on the CGI-SI range from 1 = not ill at all to 7 = among the most extremely ill. Mean change from baseline was calculated as the value at each time point minus the baseline value.
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily.
|
Paroxetine CR
n=158 Participants
An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
|
Paroxetine IR
n=83 Participants
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
|
|---|---|---|---|
|
Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8
Week 1, n=171, 157, 83
|
-0.1 scores on a scale
Standard Deviation 0.46
|
-0.2 scores on a scale
Standard Deviation 0.43
|
-0.2 scores on a scale
Standard Deviation 0.58
|
|
Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8
Week 2, n=164, 155, 80
|
-0.4 scores on a scale
Standard Deviation 0.68
|
-0.4 scores on a scale
Standard Deviation 0.59
|
-0.5 scores on a scale
Standard Deviation 0.67
|
|
Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8
Week 3, n=161, 155, 78
|
-0.6 scores on a scale
Standard Deviation 0.83
|
-0.7 scores on a scale
Standard Deviation 0.74
|
-0.6 scores on a scale
Standard Deviation 0.72
|
|
Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8
Week 4, n=158, 153, 79
|
-0.7 scores on a scale
Standard Deviation 0.85
|
-0.8 scores on a scale
Standard Deviation 0.85
|
-0.8 scores on a scale
Standard Deviation 0.93
|
|
Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8
Week 6, n=151, 147, 76
|
-0.9 scores on a scale
Standard Deviation 0.87
|
-1.1 scores on a scale
Standard Deviation 0.98
|
-0.9 scores on a scale
Standard Deviation 0.90
|
|
Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8
Week 8, n=144, 145, 74
|
-1.0 scores on a scale
Standard Deviation 0.96
|
-1.3 scores on a scale
Standard Deviation 1.02
|
-1.3 scores on a scale
Standard Deviation 1.01
|
|
Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8
Week 8 LOCF, n=171, 158, 83
|
-0.9 scores on a scale
Standard Deviation 1.02
|
-1.2 scores on a scale
Standard Deviation 1.02
|
-1.1 scores on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they had missing values or they were withdrawn prematurely.
The 7-point CGI-GI assesses the participant's improvement or worsening from baseline. Scores on the CGI-GI range from 1 = very much improved to 7 = very much worse. Responders are defined as participants with a score of 1 or 2 = much improved.
Outcome measures
| Measure |
Placebo
n=171 Participants
Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily.
|
Paroxetine CR
n=158 Participants
An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
|
Paroxetine IR
n=83 Participants
An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
|
|---|---|---|---|
|
Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8
Week 4, n=158, 153, 79
|
40 percentage of responders
|
51 percentage of responders
|
56 percentage of responders
|
|
Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8
Week 8 (OC), n=144, 145, 74
|
60 percentage of responders
|
76 percentage of responders
|
78 percentage of responders
|
|
Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8
Week 8 LOCF, n=171, 158, 83
|
53 percentage of responders
|
71 percentage of responders
|
75 percentage of responders
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 76 other events
Deaths: 0 deaths
Paroxetine CR 12.5-50 mg/Day
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Paroxetine CR 25-50 mg/Day
Serious events: 4 serious events
Other events: 50 other events
Deaths: 0 deaths
Paroxetine CR, Total
Serious events: 6 serious events
Other events: 93 other events
Deaths: 0 deaths
Paroxetine IR 10-40 mg/Day
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Paroxetine IR 20-40 mg/Day
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Paroxetine IR, Total
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=172 participants at risk
Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
|
Paroxetine CR 12.5-50 mg/Day
n=79 participants at risk
An initial dose of 12.5 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 25 mg/day, and 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
|
Paroxetine CR 25-50 mg/Day
n=82 participants at risk
An initial dose of 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
|
Paroxetine CR, Total
n=161 participants at risk
All participants receiving either paroxetine CR 12.5-50 mg/day or 25-50 mg/day
|
Paroxetine IR 10-40 mg/Day
n=43 participants at risk
An initial dose of 10 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 20 mg/day, and 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
|
Paroxetine IR 20-40 mg/Day
n=40 participants at risk
An initial dose of 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
|
Paroxetine IR, Total
n=83 participants at risk
All participants receiving either paroxetine IR 10-40 mg/day or 20-40 mg/day
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.3%
1/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.62%
1/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
2.3%
1/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.2%
1/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.2%
1/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.62%
1/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.2%
1/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.62%
1/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
2.3%
1/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.2%
1/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
2.3%
1/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.2%
1/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.58%
1/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.3%
1/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.62%
1/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Nervous system disorders
Headache
|
0.00%
0/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.2%
1/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.62%
1/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.2%
1/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.62%
1/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.2%
1/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.62%
1/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
0.00%
0/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
Other adverse events
| Measure |
Placebo
n=172 participants at risk
Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
|
Paroxetine CR 12.5-50 mg/Day
n=79 participants at risk
An initial dose of 12.5 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 25 mg/day, and 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
|
Paroxetine CR 25-50 mg/Day
n=82 participants at risk
An initial dose of 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
|
Paroxetine CR, Total
n=161 participants at risk
All participants receiving either paroxetine CR 12.5-50 mg/day or 25-50 mg/day
|
Paroxetine IR 10-40 mg/Day
n=43 participants at risk
An initial dose of 10 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 20 mg/day, and 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
|
Paroxetine IR 20-40 mg/Day
n=40 participants at risk
An initial dose of 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
|
Paroxetine IR, Total
n=83 participants at risk
All participants receiving either paroxetine IR 10-40 mg/day or 20-40 mg/day
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.1%
14/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
10.1%
8/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
25.6%
21/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
18.0%
29/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
18.6%
8/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
20.0%
8/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
19.3%
16/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
5/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
11.4%
9/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
9.8%
8/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
10.6%
17/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
9.3%
4/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
7.5%
3/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
8.4%
7/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
8/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.3%
1/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
7.3%
6/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
4.3%
7/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
9.3%
4/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
10.0%
4/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
9.6%
8/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Gastrointestinal disorders
Dry mouth
|
4.1%
7/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
3.8%
3/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
4.9%
4/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
4.3%
7/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
4.7%
2/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
7.5%
3/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
6.0%
5/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Nervous system disorders
Headache
|
10.5%
18/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
6.3%
5/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
8.5%
7/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
7.5%
12/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
4.7%
2/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
5.0%
2/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
4.8%
4/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Nervous system disorders
Somnolence
|
2.3%
4/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
13.9%
11/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
6.1%
5/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
9.9%
16/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
9.3%
4/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
7.5%
3/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
8.4%
7/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Nervous system disorders
Dizziness
|
2.3%
4/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
6.3%
5/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
7.3%
6/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
6.8%
11/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
7.0%
3/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
2.5%
1/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
4.8%
4/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Nervous system disorders
Tremor
|
0.00%
0/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
3.8%
3/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.2%
1/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
2.5%
4/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
4.7%
2/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
7.5%
3/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
6.0%
5/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Infections and infestations
Nasopharyngitis
|
19.2%
33/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
10.1%
8/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
15.9%
13/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
13.0%
21/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
9.3%
4/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
10.0%
4/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
9.6%
8/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Psychiatric disorders
Withdrawal syndrome
|
5.8%
10/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
15.2%
12/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
20.7%
17/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
18.0%
29/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
7.0%
3/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
5.0%
2/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
6.0%
5/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
|
Renal and urinary disorders
Pollakiuria
|
1.7%
3/172 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.3%
1/79 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.2%
1/82 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
1.2%
2/161 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
4.7%
2/43 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
7.5%
3/40 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
6.0%
5/83 • AEs were collected from run-in (Week -1) through the end of the follow-up phase (up to Week 13). SAEs were collected from the time a participant consented to participate in the study up to and including any follow-up contact.
|
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