Trial Outcomes & Findings for Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder (NCT NCT00105989)
NCT ID: NCT00105989
Last Updated: 2009-07-28
Results Overview
Recurrence: Clinical Global Impression-Severity (CGI-S) score \>=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
514 participants
Primary outcome timeframe
Every Visit from Week 34 up to Week 86 (Maintenance Phase)
Results posted on
2009-07-28
Participant Flow
The Acute - Open Label (Week 0-10) participants were reported in the Baseline Characteristics section of this results record.
Participant milestones
| Measure |
Duloxetine
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
|---|---|---|
|
Acute - Open Label: Week 0-10
STARTED
|
514
|
0
|
|
Acute - Open Label: Week 0-10
COMPLETED
|
413
|
0
|
|
Acute - Open Label: Week 0-10
NOT COMPLETED
|
101
|
0
|
|
Continuation - Open Label:Week 10-34
STARTED
|
413
|
0
|
|
Continuation - Open Label:Week 10-34
COMPLETED
|
288
|
0
|
|
Continuation - Open Label:Week 10-34
NOT COMPLETED
|
125
|
0
|
|
Maintenance - Double-Blind:Week 34-86
STARTED
|
146
|
142
|
|
Maintenance - Double-Blind:Week 34-86
COMPLETED
|
96
|
73
|
|
Maintenance - Double-Blind:Week 34-86
NOT COMPLETED
|
50
|
69
|
Reasons for withdrawal
| Measure |
Duloxetine
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
|---|---|---|
|
Acute - Open Label: Week 0-10
Adverse Event
|
33
|
0
|
|
Acute - Open Label: Week 0-10
Withdrawal by Subject
|
24
|
0
|
|
Acute - Open Label: Week 0-10
Lack of Efficacy
|
17
|
0
|
|
Acute - Open Label: Week 0-10
Protocol Response Criteria Not Met
|
14
|
0
|
|
Acute - Open Label: Week 0-10
Protocol Violation
|
8
|
0
|
|
Acute - Open Label: Week 0-10
Lost to Follow-up
|
4
|
0
|
|
Acute - Open Label: Week 0-10
Physician Decision
|
0
|
0
|
|
Acute - Open Label: Week 0-10
Death
|
1
|
0
|
|
Acute - Open Label: Week 0-10
Recurrence Criteria Met
|
0
|
0
|
|
Acute - Open Label: Week 0-10
Unspecified - no reason reported
|
0
|
0
|
|
Continuation - Open Label:Week 10-34
Adverse Event
|
25
|
0
|
|
Continuation - Open Label:Week 10-34
Withdrawal by Subject
|
50
|
0
|
|
Continuation - Open Label:Week 10-34
Lack of Efficacy
|
15
|
0
|
|
Continuation - Open Label:Week 10-34
Protocol Response Criteria Not Met
|
16
|
0
|
|
Continuation - Open Label:Week 10-34
Protocol Violation
|
5
|
0
|
|
Continuation - Open Label:Week 10-34
Lost to Follow-up
|
9
|
0
|
|
Continuation - Open Label:Week 10-34
Physician Decision
|
3
|
0
|
|
Continuation - Open Label:Week 10-34
Death
|
0
|
0
|
|
Continuation - Open Label:Week 10-34
Recurrence Criteria Met
|
2
|
0
|
|
Continuation - Open Label:Week 10-34
Unspecified - no reason reported
|
0
|
0
|
|
Maintenance - Double-Blind:Week 34-86
Adverse Event
|
6
|
3
|
|
Maintenance - Double-Blind:Week 34-86
Withdrawal by Subject
|
17
|
18
|
|
Maintenance - Double-Blind:Week 34-86
Lack of Efficacy
|
0
|
0
|
|
Maintenance - Double-Blind:Week 34-86
Protocol Response Criteria Not Met
|
0
|
0
|
|
Maintenance - Double-Blind:Week 34-86
Protocol Violation
|
5
|
4
|
|
Maintenance - Double-Blind:Week 34-86
Lost to Follow-up
|
4
|
0
|
|
Maintenance - Double-Blind:Week 34-86
Physician Decision
|
4
|
1
|
|
Maintenance - Double-Blind:Week 34-86
Death
|
0
|
0
|
|
Maintenance - Double-Blind:Week 34-86
Recurrence Criteria Met
|
14
|
43
|
|
Maintenance - Double-Blind:Week 34-86
Unspecified - no reason reported
|
0
|
0
|
Baseline Characteristics
Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Duloxetine
n=514 Participants
duloxetine 60-120 mg QD
|
|---|---|
|
Age Continuous
|
47.6 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
359 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
|
Region of Enrollment
France
|
65 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
99 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
161 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
73 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
55 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
504 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
5 participants
n=5 Participants
|
|
Race/Ethnicity
African
|
3 participants
n=5 Participants
|
|
Race/Ethnicity
South Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
1 participants
n=5 Participants
|
|
17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
|
23.07 units on a scale
STANDARD_DEVIATION 3.57 • n=5 Participants
|
|
Age at First Episode
|
33.16 years
STANDARD_DEVIATION 13.38 • n=5 Participants
|
|
Clinical Global Impressions - Severity (CGI-S) Total Score
|
4.49 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Duration of Current Episode
|
4.02 months
STANDARD_DEVIATION 4.65 • n=5 Participants
|
|
Duration of Last Episode
|
6.14 months
STANDARD_DEVIATION 5.29 • n=5 Participants
|
|
Height
|
167.6 centimeters
STANDARD_DEVIATION 9.23 • n=5 Participants
|
|
Number of Previous Episodes
|
4.22 previous episodes
STANDARD_DEVIATION 3.48 • n=5 Participants
|
|
Time Interval Between Episodes
|
8.38 months
STANDARD_DEVIATION 6.78 • n=5 Participants
|
|
Weight
|
74.7 kilograms
STANDARD_DEVIATION 16.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Every Visit from Week 34 up to Week 86 (Maintenance Phase)Population: All randomized patients. Intent to Treat analysis.
Recurrence: Clinical Global Impression-Severity (CGI-S) score \>=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy.
Outcome measures
| Measure |
Duloxetine
n=146 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=7 days (N=145, N=139)
|
0.68 percentage of participants
|
2.11 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=14 days (N=143, N=138)
|
1.37 percentage of participants
|
2.11 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=21 days (N=141, N=137)
|
1.37 percentage of participants
|
2.82 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=28 days (N=140, N=135)
|
2.07 percentage of participants
|
3.54 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=56 days (N=136, N=120)
|
4.19 percentage of participants
|
12.97 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=84 days (N=131, N=106)
|
6.33 percentage of participants
|
21.15 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=112 days (N=122, N=96)
|
8.58 percentage of participants
|
25.79 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=140 days (N=119, N=89)
|
9.34 percentage of participants
|
28.98 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=168 days (N=115, N=86)
|
10.89 percentage of participants
|
28.98 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=196 days (N=111, N=86)
|
11.69 percentage of participants
|
28.98 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=224 days (N=108, N=85)
|
12.50 percentage of participants
|
29.80 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=252 days (N=105, N=82)
|
13.32 percentage of participants
|
32.28 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=280 days (N=99, N=77)
|
13.32 percentage of participants
|
34.00 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=308 days (N=96, N=75)
|
13.32 percentage of participants
|
34.86 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=336 days (N=95, N=74)
|
14.23 percentage of participants
|
34.86 percentage of participants
|
—
|
|
Percentage of Participants With Depressive Recurrence After Time (t) in Days
t=364 days (N=93, N=73)
|
16.03 percentage of participants
|
35.74 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Every Visit from Week 35 up to Week 86 (Maintenance Phase)Population: Number of randomized patients with at least one non-missing postbaseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis.
Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase.
Outcome measures
| Measure |
Duloxetine
n=146 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Recurrence Count
|
21 participants
|
47 participants
|
—
|
SECONDARY outcome
Timeframe: Every Visit from Week 34 up to Week 86 (Maintenance Phase)Population: Number of randomized patients with at least one non-missing post-baseline assessment during the double blind maintenance therapy phase. Intent to Treat analysis.
Worsening occurs if patient had a \>=50% increase from baseline on the 17-Item Hamilton Depression Rating Scale (HAMD-17) total score and a Clinical Global Impression-Severity (CGI-S) score \>=3 at any time during the double-blind maintenance therapy phase.
Outcome measures
| Measure |
Duloxetine
n=146 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=308 days (N=78, N=59)
|
31.88 percentage of participants
|
46.71 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=7 days (N=142, N=140)
|
2.07 percentage of participants
|
1.41 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=14 days (N=140, N=138)
|
3.45 percentage of participants
|
1.41 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=21 days (N=136, N=130)
|
5.53 percentage of participants
|
7.12 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=28 days (N=132, N=125)
|
7.63 percentage of participants
|
9.30 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=56 days (N=124, N=105)
|
11.89 percentage of participants
|
22.57 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=84 days (N=114, N=88)
|
16.99 percentage of participants
|
31.86 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=112 days (N=105, N=81)
|
21.48 percentage of participants
|
35.07 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=140 days (N=100, N=72)
|
23.02 percentage of participants
|
40.82 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=168 days (N=95, N=70)
|
24.61 percentage of participants
|
42.47 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=196 days (N=93, N=67)
|
26.19 percentage of participants
|
44.14 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=224 days (N=90, N=65)
|
28.57 percentage of participants
|
45.80 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=252 days (N=84, N=60)
|
31.04 percentage of participants
|
45.80 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=280 days (N=81, N=60)
|
31.88 percentage of participants
|
45.80 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=336 days (N=77, N=56)
|
31.88 percentage of participants
|
49.42 percentage of participants
|
—
|
|
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
t=364 days (N=75, N=51)
|
33.65 percentage of participants
|
51.33 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Every Visit from Week 35 up to Week 86 (Maintenance Phase)Population: Number of randomized patients with at least one non-missing post-baseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis.
Loss of response was defined as a HAMD-17 total score \>9 and a CGI-Severity score \>2 at any one time during the double-blind maintenance phase of the study regardless of whether or not they subsequently regained response or not.
Outcome measures
| Measure |
Duloxetine
n=146 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Loss of Response at Any Time
|
44 participants
|
66 participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Outcome measures
| Measure |
Duloxetine
n=503 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=412 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases
Baseline
|
23.07 units on a scale
Standard Deviation 3.55
|
6.64 units on a scale
Standard Deviation 2.06
|
—
|
|
Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases
Change from Baseline to Endpoint
|
-14.37 units on a scale
Standard Deviation 6.03
|
-0.61 units on a scale
Standard Deviation 5.09
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of randomized patients with a baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Outcome measures
| Measure |
Duloxetine
n=145 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase
|
1.40 units on a scale
Standard Error 0.53
|
4.36 units on a scale
Standard Error 0.57
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Duloxetine
n=503 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=412 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases
Baseline
|
4.49 units on a scale
Standard Deviation 0.60
|
1.83 units on a scale
Standard Deviation 0.39
|
—
|
|
Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases
Change from Baseline to Endpoint
|
-2.30 units on a scale
Standard Deviation 1.08
|
-0.07 units on a scale
Standard Deviation 0.93
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Outcome measures
| Measure |
Duloxetine
n=145 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase
|
0.24 units on a scale
Standard Error 0.10
|
0.84 units on a scale
Standard Error 0.10
|
—
|
SECONDARY outcome
Timeframe: Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Duloxetine
n=488 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=412 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases
|
2.12 units on a scale
Standard Deviation 0.86
|
1.76 units on a scale
Standard Deviation 0.91
|
—
|
SECONDARY outcome
Timeframe: Week 86 (Maintenance Phase)Population: Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Duloxetine
n=145 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase
|
1.72 units on a scale
Standard Error 0.11
|
2.34 units on a scale
Standard Error 0.11
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood Item (0-4).
Outcome measures
| Measure |
Duloxetine
n=503 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=412 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Anxiety Baseline
|
7.71 units on a scale
Standard Deviation 1.99
|
2.51 units on a scale
Standard Deviation 1.40
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Anxiety Change from Baseline to Endpoint
|
-4.52 units on a scale
Standard Deviation 2.63
|
-0.11 units on a scale
Standard Deviation 2.24
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Core Baseline
|
8.81 units on a scale
Standard Deviation 1.78
|
2.00 units on a scale
Standard Deviation 1.35
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Core Change from Baseline to Endpoint
|
-5.97 units on a scale
Standard Deviation 2.69
|
-0.29 units on a scale
Standard Deviation 2.47
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Maier Baseline
|
11.44 units on a scale
Standard Deviation 1.95
|
2.91 units on a scale
Standard Deviation 1.60
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Maier Change from Baseline to Endpoint
|
-7.46 units on a scale
Standard Deviation 3.29
|
-0.29 units on a scale
Standard Deviation 2.97
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Retardation Baseline
|
7.76 units on a scale
Standard Deviation 1.53
|
2.43 units on a scale
Standard Deviation 1.37
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Retardation Change from Baseline to Endpoint
|
-4.61 units on a scale
Standard Deviation 2.37
|
-0.48 units on a scale
Standard Deviation 2.22
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Sleep Baseline
|
3.80 units on a scale
Standard Deviation 1.59
|
1.11 units on a scale
Standard Deviation 1.11
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Sleep Change from Baseline to Endpoint
|
-2.37 units on a scale
Standard Deviation 1.92
|
-0.07 units on a scale
Standard Deviation 1.38
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Depressed Mood Baseline
|
2.78 units on a scale
Standard Deviation 0.58
|
0.64 units on a scale
Standard Deviation 0.57
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Depressed Mood Change from Baseline to Endpoint
|
-1.86 units on a scale
Standard Deviation 0.98
|
-0.05 units on a scale
Standard Deviation 0.95
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.
Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood item (0-4).
Outcome measures
| Measure |
Duloxetine
n=145 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase
Change from Baseline to Endpoint in Anxiety
|
0.46 units on a scale
Standard Error 0.20
|
1.54 units on a scale
Standard Error 0.22
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase
Change from Baseline to Endpoint in Core
|
0.75 units on a scale
Standard Error 0.22
|
1.74 units on a scale
Standard Error 0.24
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase
Change from Baseline to Endpoint in Maier
|
0.91 units on a scale
Standard Error 0.29
|
2.25 units on a scale
Standard Error 0.31
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase
Change from Baseline to Endpoint in Retardation
|
0.59 units on a scale
Standard Error 0.20
|
1.49 units on a scale
Standard Error 0.22
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase
Change from Baseline to Endpoint in Sleep
|
0.13 units on a scale
Standard Error 0.12
|
0.71 units on a scale
Standard Error 0.13
|
—
|
|
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase
Change from Baseline to Endpoint in Depressed Mood
|
0.27 units on a scale
Standard Error 0.09
|
0.67 units on a scale
Standard Error 0.10
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).
Outcome measures
| Measure |
Duloxetine
n=450 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=410 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Overall Pain Baseline (N=450, N=410)
|
34.36 units on a scale
Standard Deviation 26.16
|
17.29 units on a scale
Standard Deviation 20.20
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Overall Pain Change from Baseline to Endpoint
|
-16.34 units on a scale
Standard Deviation 26.95
|
1.16 units on a scale
Standard Deviation 21.33
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Headache Baseline (N=450, N=410)
|
29.74 units on a scale
Standard Deviation 28.08
|
14.80 units on a scale
Standard Deviation 20.53
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Headache Change from Baseline to Endpoint
|
-14.83 units on a scale
Standard Deviation 28.04
|
0.04 units on a scale
Standard Deviation 21.88
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Back Pain Baseline (N=450, N=410)
|
28.79 units on a scale
Standard Deviation 27.80
|
15.61 units on a scale
Standard Deviation 22.63
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Back Pain Change from Baseline to Endpoint
|
-13.64 units on a scale
Standard Deviation 25.66
|
-0.00 units on a scale
Standard Deviation 20.95
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Shoulder Pain Baseline (N=446, N=410)
|
24.06 units on a scale
Standard Deviation 27.23
|
13.49 units on a scale
Standard Deviation 21.95
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Shoulder Pain Change from Baseline to Endpoint
|
-10.47 units on a scale
Standard Deviation 24.25
|
-0.39 units on a scale
Standard Deviation 20.84
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Interference-DailyActivities Baseline(N=445,N=410)
|
33.28 units on a scale
Standard Deviation 28.31
|
15.59 units on a scale
Standard Deviation 21.62
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Intereference Change from Baseline to Endpoint
|
-16.79 units on a scale
Standard Deviation 29.77
|
1.00 units on a scale
Standard Deviation 21.43
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Pain While Awake Baseline (N=446, N=410)
|
38.18 units on a scale
Standard Deviation 29.29
|
19.22 units on a scale
Standard Deviation 25.63
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Pain While Awake Change from Baseline to Endpoint
|
-17.66 units on a scale
Standard Deviation 31.22
|
0.06 units on a scale
Standard Deviation 25.61
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).
Outcome measures
| Measure |
Duloxetine
n=146 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase
Change from Baseline to Endpoint in Overall Pain
|
3.92 units on a scale
Standard Error 1.78
|
4.57 units on a scale
Standard Error 1.86
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase
Change from Baseline to Endpoint in Headache
|
4.77 units on a scale
Standard Error 1.72
|
2.80 units on a scale
Standard Error 1.80
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase
Change from Baseline to Endpoint in Back Pain
|
1.77 units on a scale
Standard Error 1.65
|
3.40 units on a scale
Standard Error 1.72
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase
Change from Baseline to Endpoint in Shoulder Pain
|
0.51 units on a scale
Standard Error 1.55
|
3.02 units on a scale
Standard Error 1.62
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase
Change: Interference with Daily Activities
|
3.16 units on a scale
Standard Error 1.74
|
2.81 units on a scale
Standard Error 1.82
|
—
|
|
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase
Change from Baseline in Pain While Awake
|
3.64 units on a scale
Standard Error 2.10
|
4.69 units on a scale
Standard Error 2.19
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.
Outcome measures
| Measure |
Duloxetine
n=448 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=376 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases
Baseline
|
12.64 units on a scale
Standard Deviation 5.09
|
6.88 units on a scale
Standard Deviation 5.13
|
—
|
|
Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases
Change from Baseline to Endpoint
|
-5.37 units on a scale
Standard Deviation 5.42
|
-0.35 units on a scale
Standard Deviation 4.80
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.
The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.
Outcome measures
| Measure |
Duloxetine
n=145 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=140 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase
|
0.79 units on a scale
Standard Error 0.39
|
0.81 units on a scale
Standard Error 0.40
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.
Outcome measures
| Measure |
Duloxetine
n=452 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=378 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases
Global Score Baseline (N=449,N=378)
|
19.30 units on a scale
Standard Deviation 6.58
|
10.72 units on a scale
Standard Deviation 7.21
|
—
|
|
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases
Global Score Change from Baseline to Endpoint
|
-7.88 units on a scale
Standard Deviation 8.06
|
-2.01 units on a scale
Standard Deviation 7.67
|
—
|
|
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases
Work/School Item Baseline (N=452,N=378)
|
6.52 units on a scale
Standard Deviation 2.52
|
3.64 units on a scale
Standard Deviation 2.64
|
—
|
|
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases
Work/School Item Change from Baseline to Endpoint
|
-2.61 units on a scale
Standard Deviation 2.87
|
-0.71 units on a scale
Standard Deviation 2.86
|
—
|
|
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases
Social Life Item Baseline (N=452,N=378)
|
6.45 units on a scale
Standard Deviation 2.42
|
3.50 units on a scale
Standard Deviation 2.53
|
—
|
|
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases
Social Life Item Change from Baseline to Endpoint
|
-2.69 units on a scale
Standard Deviation 2.90
|
-0.64 units on a scale
Standard Deviation 2.79
|
—
|
|
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases
Family Life Item Baseline (N=452,N=378)
|
6.35 units on a scale
Standard Deviation 2.44
|
3.54 units on a scale
Standard Deviation 2.57
|
—
|
|
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases
Family Life Item Change from Baseline to Endpoint
|
-2.59 units on a scale
Standard Deviation 3.07
|
-0.63 units on a scale
Standard Deviation 2.72
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.
Outcome measures
| Measure |
Duloxetine
n=128 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=117 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase
Change from Baseline to Endpoint in Global Score
|
-0.05 units on a scale
Standard Error 0.71
|
2.06 units on a scale
Standard Error 0.77
|
—
|
|
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase
Change from Baseline to Endpoint in Work/School
|
0.03 units on a scale
Standard Error 0.26
|
0.83 units on a scale
Standard Error 0.28
|
—
|
|
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase
Change from Baseline to Endpoint in Social Life
|
0.02 units on a scale
Standard Error 0.25
|
0.56 units on a scale
Standard Error 0.27
|
—
|
|
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase
Change from Baseline to Endpoint in Family Life
|
-0.10 units on a scale
Standard Error 0.25
|
0.67 units on a scale
Standard Error 0.27
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.
Outcome measures
| Measure |
Duloxetine
n=460 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=377 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Physical Component Summary Baseline (N=455,N=377)
|
43.55 units on a scale
Standard Deviation 9.46
|
48.05 units on a scale
Standard Deviation 8.65
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Physical Component Summary Change to Endpoint
|
3.86 units on a scale
Standard Deviation 8.66
|
0.03 units on a scale
Standard Deviation 7.63
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Mental Component Summary Baseline (N=455,N=377)
|
23.93 units on a scale
Standard Deviation 8.76
|
39.83 units on a scale
Standard Deviation 10.68
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Mental Component Summary Change to Endpoint
|
14.67 units on a scale
Standard Deviation 11.77
|
3.98 units on a scale
Standard Deviation 12.63
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Physical Functioning Baseline (N=457,N=377)
|
23.59 units on a scale
Standard Deviation 4.75
|
26.28 units on a scale
Standard Deviation 4.05
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Physical Functioning Change to Endpoint
|
2.39 units on a scale
Standard Deviation 4.40
|
0.28 units on a scale
Standard Deviation 3.42
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Bodily Pain Baseline (N=460,N=377)
|
6.83 units on a scale
Standard Deviation 2.45
|
8.61 units on a scale
Standard Deviation 2.35
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Bodily Pain Change from Baseline to Endpoint
|
1.61 units on a scale
Standard Deviation 2.50
|
0.07 units on a scale
Standard Deviation 2.39
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Role Limitations:Physical Baseline (N=457,N=377)
|
5.24 units on a scale
Standard Deviation 1.47
|
6.48 units on a scale
Standard Deviation 1.54
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Role Limitations:Physical Change to Endpoint
|
1.06 units on a scale
Standard Deviation 1.78
|
0.20 units on a scale
Standard Deviation 1.74
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Role Limitations:Emotional Baseline (N=456,N=377)
|
3.42 units on a scale
Standard Deviation 0.80
|
4.65 units on a scale
Standard Deviation 1.25
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Role Limitations:Emotional Change to Endpoint
|
1.11 units on a scale
Standard Deviation 1.31
|
0.34 units on a scale
Standard Deviation 1.49
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
General Health Perceptions Baseline(N=456,N=377)
|
13.66 units on a scale
Standard Deviation 3.62
|
17.03 units on a scale
Standard Deviation 3.80
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
General Health Perceptions Change to Endpoint
|
2.93 units on a scale
Standard Deviation 3.74
|
0.58 units on a scale
Standard Deviation 3.52
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Mental Health Baseline (N=456,N=377)
|
12.62 units on a scale
Standard Deviation 4.13
|
19.60 units on a scale
Standard Deviation 4.39
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Mental Health Change from Baseline to Endpoint
|
6.45 units on a scale
Standard Deviation 5.31
|
1.30 units on a scale
Standard Deviation 5.34
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Social Function Baseline (N=460,N=377)
|
4.77 units on a scale
Standard Deviation 1.74
|
7.05 units on a scale
Standard Deviation 1.80
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Social Function Change from Baseline to Endpoint
|
2.12 units on a scale
Standard Deviation 2.04
|
0.65 units on a scale
Standard Deviation 2.19
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Vitality Baseline (N=457,N=377)
|
8.85 units on a scale
Standard Deviation 3.26
|
13.84 units on a scale
Standard Deviation 3.79
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Vitality Change from Baseline to Endpoint
|
4.51 units on a scale
Standard Deviation 4.22
|
0.84 units on a scale
Standard Deviation 4.40
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Rate Current Health Baseline (N=460,N=377)
|
3.88 units on a scale
Standard Deviation 0.85
|
3.03 units on a scale
Standard Deviation 0.83
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Rate Current Health Change to Endpoint
|
-0.72 units on a scale
Standard Deviation 0.95
|
-0.01 units on a scale
Standard Deviation 0.88
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Health Compared to Year Ago Baseline (N=460,N=377)
|
3.67 units on a scale
Standard Deviation 0.99
|
2.37 units on a scale
Standard Deviation 1.05
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Health Compared to Year Ago Change to Endpoint
|
-1.18 units on a scale
Standard Deviation 1.28
|
-0.34 units on a scale
Standard Deviation 1.13
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.
Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.
Outcome measures
| Measure |
Duloxetine
n=129 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=118 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Change from Baseline-Physical Component Summary
|
-0.45 units on a scale
Standard Error 0.70
|
0.33 units on a scale
Standard Error 0.76
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Change from Baseline-Mental Component Summary
|
-1.11 units on a scale
Standard Error 1.11
|
-5.74 units on a scale
Standard Error 1.20
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Change from Baseline-Physical Functioning
|
0.06 units on a scale
Standard Error 0.28
|
-0.07 units on a scale
Standard Error 0.31
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Change from Baseline-Bodily Pain
|
-0.42 units on a scale
Standard Error 0.22
|
-0.19 units on a scale
Standard Error 0.24
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Change from Baseline-Role Limitations: Physical
|
0.01 units on a scale
Standard Error 0.14
|
-0.41 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Change from Baseline-Role Limitations: Emotional
|
-0.03 units on a scale
Standard Error 0.11
|
-0.46 units on a scale
Standard Error 0.11
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Change from Baseline-General Health Perceptions
|
-0.23 units on a scale
Standard Error 0.33
|
-0.61 units on a scale
Standard Error 0.36
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Change from Baseline-Mental Health
|
-0.44 units on a scale
Standard Error 0.49
|
-2.60 units on a scale
Standard Error 0.53
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Change from Baseline-Social Function
|
-0.14 units on a scale
Standard Error 0.18
|
-0.50 units on a scale
Standard Error 0.20
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Change from Baseline-Vitality
|
-0.77 units on a scale
Standard Error 0.38
|
-1.38 units on a scale
Standard Error 0.41
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Change from Baseline-Rate Current Health
|
0.03 units on a scale
Standard Error 0.08
|
0.08 units on a scale
Standard Error 0.08
|
—
|
|
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Change from Baseline-Health Compared to Year Ago
|
0.19 units on a scale
Standard Error 0.09
|
0.34 units on a scale
Standard Error 0.10
|
—
|
SECONDARY outcome
Timeframe: Week 0 through Week10 (Acute) through Week 34 (Continuation)Population: Number of enrolled patients in Acute Phase and number who entered Continuation Phase who indicated they had visits to specified health care provider. Intent to Treat analysis. Note: "Other Mental Health Care Worker" wasn't included in table (1 patient in Acute). "Other Health Care Worker" wasn't included in table (2 patients in Continuation).
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.
Outcome measures
| Measure |
Duloxetine
n=514 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=413 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases
Primary Health Care Provider Visits (N=94,N=99)
|
-0.00 visits
Standard Deviation 0.03
|
-0.00 visits
Standard Deviation 0.03
|
—
|
|
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases
Psychiatrist Visits (N=91,N=65)
|
0.03 visits
Standard Deviation 0.03
|
-0.03 visits
Standard Deviation 0.04
|
—
|
|
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases
Psychologist/Therapist Visits (N=19,N=11)
|
0.01 visits
Standard Deviation 0.04
|
-0.00 visits
Standard Deviation 0.06
|
—
|
|
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases
Other Specialist Physician Visits (N=42,N=38)
|
-0.00 visits
Standard Deviation 0.02
|
0.01 visits
Standard Deviation 0.03
|
—
|
|
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases
Other (Specified by Patient) Visits (N=3,N=3)
|
0.04 visits
Standard Deviation 0.07
|
-0.07 visits
Standard Deviation 0.10
|
—
|
SECONDARY outcome
Timeframe: Week 34 through Week 86 (Maintenance Phase)Population: Number of randomized patients who indicated they had visits to specified health care provider. Intent to Treat analysis.
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.
Outcome measures
| Measure |
Duloxetine
n=146 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase
Primary Health Care Provider Visits (N=47,N=47)
|
-0.00 visits
Standard Error 0.00
|
-0.00 visits
Standard Error 0.00
|
—
|
|
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase
Psychiatrist Visits (N=33,N=23)
|
-0.01 visits
Standard Error 0.00
|
-0.01 visits
Standard Error 0.01
|
—
|
|
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase
Psychologist/Therapist Visits (N=8,N=7)
|
-0.02 visits
Standard Error 0.01
|
-0.01 visits
Standard Error 0.01
|
—
|
|
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase
Other Specialist Physician Visits (N=25,N=25)
|
0.00 visits
Standard Error 0.01
|
-0.00 visits
Standard Error 0.00
|
—
|
|
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase
Other (Specified by Patient) Visits (N=5,N=3)
|
0.04 visits
Standard Error 0.02
|
0.00 visits
Standard Error 0.00
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase who work for pay. Number of patients who entered the Continuation Phase who work for pay. Intent to Treat analysis.
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.
Outcome measures
| Measure |
Duloxetine
n=224 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=196 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases
Average Number of Hours Worked In a Week Baseline
|
0.36 hours
Standard Deviation 0.10
|
0.36 hours
Standard Deviation 0.10
|
—
|
|
Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases
Change in Average Number of Hours Worked In a Week
|
0.00 hours
Standard Deviation 0.06
|
0.01 hours
Standard Deviation 0.08
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of randomized patients who work for pay. Intent to Treat analysis.
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.
Outcome measures
| Measure |
Duloxetine
n=87 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=83 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase
|
-0.00 hours
Standard Error 0.01
|
-0.00 hours
Standard Error 0.01
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase who work for pay and missed work due to illness. Number of patients who entered the Continuation Phase who work for pay and missed work due to illness. Intent to Treat analysis.
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.
Outcome measures
| Measure |
Duloxetine
n=64 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=29 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase
Number of Missed Paid Work Hours Baseline
|
1.77 hours
Standard Deviation 2.07
|
2.67 hours
Standard Deviation 2.27
|
—
|
|
Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase
Change in Number of Missed Paid Work Hours
|
0.46 hours
Standard Deviation 2.25
|
-0.52 hours
Standard Deviation 2.01
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of randomized patients who work for pay and missed work due to illness. Intent to Treat analysis.
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.
Outcome measures
| Measure |
Duloxetine
n=13 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=16 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase
|
0.27 hours
Standard Error 0.28
|
-0.75 hours
Standard Error 0.35
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of male enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of male patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.
Outcome measures
| Measure |
Duloxetine
n=136 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=109 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Sum Items 1 to 5 Baseline (N=117,N=97)
|
17.57 units on a scale
Standard Deviation 4.88
|
17.26 units on a scale
Standard Deviation 4.51
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Sum Items 1 to 5 Change to Endpoint
|
0.13 units on a scale
Standard Deviation 5.08
|
-0.67 units on a scale
Standard Deviation 3.97
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Sum Items 1&2 Baseline (N=135, N=109)
|
7.47 units on a scale
Standard Deviation 2.19
|
7.16 units on a scale
Standard Deviation 1.96
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Sum Items 1&2 Change to Endpoint
|
-0.19 units on a scale
Standard Deviation 2.32
|
-0.39 units on a scale
Standard Deviation 1.76
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Item 1-Sex Drive Baseline (N=136,N=109)
|
3.91 units on a scale
Standard Deviation 1.20
|
3.68 units on a scale
Standard Deviation 1.14
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Item 1-Sex Drive Change to Endpoint
|
-0.15 units on a scale
Standard Deviation 1.30
|
-0.21 units on a scale
Standard Deviation 1.10
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Item 2-Arousal Baseline (N=135, N=109)
|
3.56 units on a scale
Standard Deviation 1.11
|
3.48 units on a scale
Standard Deviation 0.95
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Item 2-Arousal Change to Endpoint
|
-0.02 units on a scale
Standard Deviation 1.17
|
-0.18 units on a scale
Standard Deviation 0.83
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Item 3-Lubrication/Erection Baseline (N=124,N=99)
|
3.43 units on a scale
Standard Deviation 1.13
|
3.27 units on a scale
Standard Deviation 1.02
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Item 3-Lubrication Change to Endpoint
|
-0.02 units on a scale
Standard Deviation 1.15
|
-0.04 units on a scale
Standard Deviation 0.94
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Item 4-Orgasm Baseline (N=120,N=98)
|
3.38 units on a scale
Standard Deviation 1.10
|
3.60 units on a scale
Standard Deviation 1.03
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Item 4-Orgasm Change to Endpoint
|
0.32 units on a scale
Standard Deviation 1.30
|
-0.15 units on a scale
Standard Deviation 1.01
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Item 5-Satisfaction Baseline (N=118,N=97)
|
3.36 units on a scale
Standard Deviation 1.17
|
3.32 units on a scale
Standard Deviation 1.20
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
Item 5-Satisfaction Change to Endpoint
|
0.05 units on a scale
Standard Deviation 1.29
|
-0.15 units on a scale
Standard Deviation 1.05
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of female enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of female patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.
Outcome measures
| Measure |
Duloxetine
n=286 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=239 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Sum Items 1 to 5 Baseline (N=220,N=197)
|
21.41 units on a scale
Standard Deviation 5.17
|
19.31 units on a scale
Standard Deviation 4.94
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Sum Items 1 to 5 Change to Endpoint
|
-1.31 units on a scale
Standard Deviation 3.91
|
-0.99 units on a scale
Standard Deviation 4.38
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Sum Items 1&2 Baseline (N=285,N=239)
|
9.31 units on a scale
Standard Deviation 2.08
|
8.42 units on a scale
Standard Deviation 2.28
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Sum Items 1&2 Change to Endpoint
|
-0.69 units on a scale
Standard Deviation 1.91
|
-0.56 units on a scale
Standard Deviation 1.92
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Item 1-Sex Drive Baseline (N=286,N=239)
|
4.92 units on a scale
Standard Deviation 1.12
|
4.34 units on a scale
Standard Deviation 1.20
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Item 1-Sex Drive Change to Endpoint
|
-0.46 units on a scale
Standard Deviation 1.05
|
-0.31 units on a scale
Standard Deviation 1.09
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Item 2-Arousal Baseline (N=286,N=239)
|
4.40 units on a scale
Standard Deviation 1.13
|
4.08 units on a scale
Standard Deviation 1.19
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Item 2-Arousal Change to Endpoint
|
-0.22 units on a scale
Standard Deviation 1.07
|
-0.25 units on a scale
Standard Deviation 1.02
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Item 3-Lubrication/Erection Baseline (N=224,N=198)
|
3.97 units on a scale
Standard Deviation 1.26
|
3.57 units on a scale
Standard Deviation 1.20
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Item 3-Lubrication/Erection Change to Endpoint
|
-0.19 units on a scale
Standard Deviation 0.98
|
-0.10 units on a scale
Standard Deviation 1.07
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Item 4-Orgasm Baseline (N=224,N=198)
|
4.33 units on a scale
Standard Deviation 1.19
|
4.06 units on a scale
Standard Deviation 1.08
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Item4-Orgasm Change to Endpoint
|
-0.13 units on a scale
Standard Deviation 1.02
|
-0.28 units on a scale
Standard Deviation 1.05
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Item 5-Satisfaction Baseline (N=226,N=198)
|
3.93 units on a scale
Standard Deviation 1.39
|
3.58 units on a scale
Standard Deviation 1.31
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
Item 5-Satisfaction Change to Endpoint
|
-0.18 units on a scale
Standard Deviation 1.18
|
-0.10 units on a scale
Standard Deviation 1.32
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: N=Number of male randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Male patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis.
A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.
Outcome measures
| Measure |
Duloxetine
n=39 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=29 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)
Change from Baseline: Sum Items 1 to 5 (N=35,N=29)
|
-0.97 units on a scale
Standard Error 0.47
|
-0.77 units on a scale
Standard Error 0.58
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)
Change from Baseline: Sum Items 1&2 (N=39,N=29)
|
-0.25 units on a scale
Standard Error 0.22
|
0.03 units on a scale
Standard Error 0.28
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)
Item 1-Sex Drive (N=39,N=29)
|
-0.17 units on a scale
Standard Error 0.13
|
-0.02 units on a scale
Standard Error 0.17
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)
Item 2-Arousal (N=39,N=29)
|
-0.09 units on a scale
Standard Error 0.12
|
0.07 units on a scale
Standard Error 0.15
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)
Item 3-Lubrication/Erection (N=38,N=29)
|
-0.32 units on a scale
Standard Error 0.14
|
-0.10 units on a scale
Standard Error 0.17
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)
Item 4-Orgasm (N=36,N=29)
|
-0.08 units on a scale
Standard Error 0.14
|
-0.43 units on a scale
Standard Error 0.17
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)
Item 5-Satisfaction (N=35,N=29)
|
-0.13 units on a scale
Standard Error 0.11
|
-0.04 units on a scale
Standard Error 0.13
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: N=Number of female randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Female patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis.
A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.
Outcome measures
| Measure |
Duloxetine
n=77 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=79 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)
Change from Baseline:Sum Items 1 to 5 (N=63,N=66)
|
-0.65 units on a scale
Standard Error 4.14
|
-0.47 units on a scale
Standard Error 4.34
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)
Change from Baseline:Sum Items 1&2 (N=77,N=79)
|
-0.19 units on a scale
Standard Error 1.90
|
0.34 units on a scale
Standard Error 1.91
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)
Item 1 - Sex Drive (N=77,N=79)
|
-0.08 units on a scale
Standard Error 1.11
|
0.18 units on a scale
Standard Error 1.07
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)
Item 2 - Arousal (N=77,N=79)
|
-0.12 units on a scale
Standard Error 0.95
|
0.16 units on a scale
Standard Error 1.06
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)
Item 3 - Lubrication/Erection (N=63,N=67)
|
-0.21 units on a scale
Standard Error 0.92
|
-0.15 units on a scale
Standard Error 1.21
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)
Item 4 - Orgasm (N=63,N=67)
|
-0.10 units on a scale
Standard Error 0.96
|
-0.15 units on a scale
Standard Error 1.06
|
—
|
|
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)
Item 5 - Satisfaction (N=63,N=67)
|
-0.05 units on a scale
Standard Error 1.25
|
-0.40 units on a scale
Standard Error 1.21
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=503 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=412 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases
Weight Baseline
|
74.74 kilograms
Standard Deviation 16.25
|
74.22 kilograms
Standard Deviation 15.89
|
—
|
|
Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases
Weight Change from Baseline to Endpoint
|
-0.69 kilograms
Standard Deviation 2.12
|
0.88 kilograms
Standard Deviation 3.29
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=145 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase
|
0.88 kilograms
Standard Error 0.36
|
0.39 kilograms
Standard Error 0.37
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=502 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=412 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases
Pulse Baseline
|
71.76 beats per minute
Standard Deviation 9.26
|
72.79 beats per minute
Standard Deviation 9.50
|
—
|
|
Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases
Pulse Change from Baseline to Endpoint
|
1.42 beats per minute
Standard Deviation 9.18
|
1.75 beats per minute
Standard Deviation 10.39
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=145 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase
|
-1.86 beats per minute
Standard Error 0.76
|
-1.72 beats per minute
Standard Error 0.78
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10 (Acute) and Week 34 (Continuation)Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=503 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=412 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases
Systolic Blood Pressure Baseline
|
125.03 mm Hg
Standard Deviation 14.65
|
124.72 mm Hg
Standard Deviation 13.84
|
—
|
|
Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases
Systolic Blood Pressure Change to Endpoint
|
0.25 mm Hg
Standard Deviation 12.62
|
0.77 mm Hg
Standard Deviation 12.83
|
—
|
|
Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases
Diastolic Blood Pressure Baseline
|
77.52 mm Hg
Standard Deviation 9.54
|
78.28 mm Hg
Standard Deviation 9.19
|
—
|
|
Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases
Diastolic Blood Pressure Change to Endpoint
|
0.72 mm Hg
Standard Deviation 8.68
|
-0.57 mm Hg
Standard Deviation 9.18
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=145 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=142 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase
Change from Baseline: Systolic Blood Pressure
|
1.70 mm Hg
Standard Error 13.44
|
-1.11 mm Hg
Standard Error 11.59
|
—
|
|
Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase
Change from Baseline: Diastolic Blood Pressure
|
-0.23 mm Hg
Standard Error 9.72
|
-0.11 mm Hg
Standard Error 8.69
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=430 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase
Baseline
|
43.05 grams per Liter
Standard Deviation 3.31
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase
Change to Endpoint
|
-0.61 grams per Liter
Standard Deviation 2.90
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=435 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase
Baseline
|
2.46 millimoles per Liter
Standard Deviation 0.10
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase
Change to Endpoint
|
-0.01 millimoles per Liter
Standard Deviation 0.10
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=435 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase
Baseline
|
103.73 millimoles per Liter
Standard Deviation 2.66
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase
Change to Endpoint
|
-0.29 millimoles per Liter
Standard Deviation 2.81
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=423 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase
Baseline
|
0.13 Giga per Liter
Standard Deviation 0.09
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase
Change to Endpoint
|
0.01 Giga per Liter
Standard Deviation 0.09
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=434 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase
Baseline
|
29.25 Units per Liter
Standard Deviation 36.30
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase
Change to Endpoint
|
-5.12 Units per Liter
Standard Deviation 20.53
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=416 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase
Baseline
|
0.43 actual count
Standard Deviation 0.04
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase
Change to Endpoint
|
-0.00 actual count
Standard Deviation 0.03
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=423 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase
Baseline
|
8.81 millimoles per Liter
Standard Deviation 0.80
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase
Change to Endpoint
|
-0.07 millimoles per Liter
Standard Deviation 0.48
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=422 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase
Baseline
|
261.08 Giga per Liter
Standard Deviation 60.89
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase
Change to Endpoint
|
4.23 Giga per Liter
Standard Deviation 40.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=435 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase
Baseline
|
141.21 millimoles per Liter
Standard Deviation 2.65
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase
Change to Endpoint
|
-0.64 millimoles per Liter
Standard Deviation 2.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=435 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase
Baseline
|
73.59 grams per Liter
Standard Deviation 4.40
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase
Change to Endpoint
|
-1.18 grams per Liter
Standard Deviation 4.11
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 10Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=435 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase
Baseline
|
297.05 micromoles per Liter
Standard Deviation 81.68
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase
Change to Endpoint
|
-10.64 micromoles per Liter
Standard Deviation 49.42
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=390 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase
Baseline
|
42.43 grams per Liter
Standard Deviation 3.04
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase
Change to Endpoint
|
-0.57 grams per Liter
Standard Deviation 2.81
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=389 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase
Baseline
|
24.41 millimoles per Liter
Standard Deviation 2.64
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase
Change to Endpoint
|
1.04 millimoles per Liter
Standard Deviation 2.93
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=388 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase
Baseline
|
2.03 micromoles per Liter
Standard Deviation 1.04
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase
Change to Endpoint
|
-0.12 micromoles per Liter
Standard Deviation 0.85
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=390 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase
Baseline
|
8.68 micromoles per Liter
Standard Deviation 5.10
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase
Change to Endpoint
|
-0.50 micromoles per Liter
Standard Deviation 3.84
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=391 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase
Baseline
|
2.45 millimoles per Liter
Standard Deviation 0.10
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase
Change to Endpoint
|
-0.01 millimoles per Liter
Standard Deviation 0.10
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=386 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase
Baseline
|
4.74 Tera per Liter
Standard Deviation 0.45
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase
Change to Endpoint
|
-0.06 Tera per Liter
Standard Deviation 0.25
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=392 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase
Baseline
|
24.13 Units per Liter
Standard Deviation 24.96
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase
Change to Endpoint
|
2.11 Units per Liter
Standard Deviation 17.11
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=384 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase
Baseline
|
0.42 Actual count
Standard Deviation 0.04
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase
Change to Endpoint
|
-0.00 Actual count
Standard Deviation 0.03
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=386 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase
Baseline
|
8.73 millimoles per Liter
Standard Deviation 0.80
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase
Change to Endpoint
|
-0.14 millimoles per Liter
Standard Deviation 0.47
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=386 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase
Baseline
|
6.40 Giga per Liter
Standard Deviation 1.69
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase
Change to Endpoint
|
0.17 Giga per Liter
Standard Deviation 1.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=340 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase
Baseline
|
3.61 millimoles per Liter
Standard Deviation 1.07
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase
Change to Endpoint
|
-0.14 millimoles per Liter
Standard Deviation 0.73
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=384 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase
Baseline
|
20.73 millimoles per Liter
Standard Deviation 0.87
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase
Change to Endpoint
|
-0.18 millimoles per Liter
Standard Deviation 0.99
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=384 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase
Baseline
|
89.33 femtoliters
Standard Deviation 5.10
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase
Change to Endpoint
|
0.45 femtoliters
Standard Deviation 4.00
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=386 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase
Baseline
|
0.35 Giga per Liter
Standard Deviation 0.12
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase
Change to Endpoint
|
0.02 Giga per Liter
Standard Deviation 0.12
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=392 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase
Baseline
|
72.47 grams per Liter
Standard Deviation 3.93
|
—
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase
Change to Endpoint
|
-0.38 grams per Liter
Standard Deviation 3.77
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=143 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=133 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase
Baseline
|
21.81 Units per Liter
Standard Deviation 11.56
|
22.12 Units per Liter
Standard Deviation 11.11
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase
Change to Endpoint
|
2.52 Units per Liter
Standard Deviation 15.40
|
-0.38 Units per Liter
Standard Deviation 12.53
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=143 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=133 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase
Baseline
|
2.43 millimoles per Liter
Standard Deviation 0.10
|
2.43 millimoles per Liter
Standard Deviation 0.08
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase
Change to Endpoint
|
-0.04 millimoles per Liter
Standard Deviation 0.10
|
-0.01 millimoles per Liter
Standard Deviation 0.09
|
—
|
SECONDARY outcome
Timeframe: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=120 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=112 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase
Fasting Glucose Baseline (N=120,N=112)
|
5.40 millimoles per Liter
Standard Deviation 0.72
|
5.47 millimoles per Liter
Standard Deviation 1.09
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase
Fasting Glucose Change to Endpoint
|
0.07 millimoles per Liter
Standard Deviation 0.71
|
0.03 millimoles per Liter
Standard Deviation 1.01
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase
Non-Fasting Glucose Baseline (N=41,N=39)
|
5.68 millimoles per Liter
Standard Deviation 0.91
|
5.74 millimoles per Liter
Standard Deviation 2.34
|
—
|
|
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase
Non-Fasting Glucose Change to Endpoint
|
-0.20 millimoles per Liter
Standard Deviation 1.18
|
0.62 millimoles per Liter
Standard Deviation 1.67
|
—
|
SECONDARY outcome
Timeframe: Every Visit from Week 0 up to Week 10 (Acute)Population: Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=514 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Patients with >= 1 Adverse Event
|
349 participants
|
—
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Nausea
|
150 participants
|
—
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Headache
|
79 participants
|
—
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Dry mouth
|
76 participants
|
—
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Hyperhidrosis
|
76 participants
|
—
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Fatigue
|
60 participants
|
—
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Constipation
|
48 participants
|
—
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Dizziness
|
41 participants
|
—
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Diarrhoea
|
38 participants
|
—
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Vomiting
|
28 participants
|
—
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Insomnia
|
27 participants
|
—
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Decreased appetite
|
26 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Every Visit from Week 10 up to Week 34 (Continuation)Population: Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis.
Outcome measures
| Measure |
Duloxetine
n=175 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
|
Placebo
n=128 Participants
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
|
Duloxetine 120 mg
n=110 Participants
duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
|
|---|---|---|---|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase
Hyperhidrosis
|
8 participants
|
12 participants
|
5 participants
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase
Patients with >= 1 Adverse Event
|
102 participants
|
83 participants
|
59 participants
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase
Headache
|
21 participants
|
12 participants
|
6 participants
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase
Nasopharyngitis
|
7 participants
|
10 participants
|
9 participants
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase
Back pain
|
7 participants
|
4 participants
|
8 participants
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase
Diarrhoea
|
10 participants
|
6 participants
|
2 participants
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 105 other events
Deaths: 0 deaths
Duloxetine 60 mg
Serious events: 5 serious events
Other events: 51 other events
Deaths: 0 deaths
Duloxetine 90 mg
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Duloxetine 120 mg
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
Placebo
|
Duloxetine 60 mg
Duloxetine 60 mg
|
Duloxetine 90 mg
Duloxetine 90 mg
|
Duloxetine 120 mg
Duloxetine 120 mg
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/142
|
0.00%
0/64
|
0.00%
0/45
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/142
|
1.6%
1/64 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
0.00%
0/37
|
|
Infections and infestations
Abscess
|
0.00%
0/142
|
0.00%
0/64
|
2.2%
1/45 • Number of events 1
|
0.00%
0/37
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/142
|
1.6%
1/64 • Number of events 1
|
0.00%
0/45
|
0.00%
0/37
|
|
Infections and infestations
Pneumonia chlamydial
|
0.00%
0/142
|
0.00%
0/64
|
2.2%
1/45 • Number of events 1
|
0.00%
0/37
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/142
|
0.00%
0/64
|
2.2%
1/45 • Number of events 1
|
0.00%
0/37
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/142
|
1.6%
1/64 • Number of events 1
|
0.00%
0/45
|
0.00%
0/37
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.70%
1/142 • Number of events 1
|
0.00%
0/64
|
0.00%
0/45
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.70%
1/142 • Number of events 1
|
0.00%
0/64
|
0.00%
0/45
|
2.7%
1/37 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.70%
1/142 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
0.00%
0/45
|
0.00%
0/37
|
|
Nervous system disorders
Migraine
|
0.00%
0/142
|
1.6%
1/64 • Number of events 1
|
0.00%
0/45
|
0.00%
0/37
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/142
|
0.00%
0/64
|
0.00%
0/45
|
2.7%
1/37 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/142
|
0.00%
0/64
|
0.00%
0/45
|
2.7%
1/37 • Number of events 1
|
|
Psychiatric disorders
Major depression
|
0.70%
1/142 • Number of events 1
|
0.00%
0/64
|
0.00%
0/45
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.70%
1/142 • Number of events 1
|
0.00%
0/64
|
0.00%
0/45
|
0.00%
0/37
|
Other adverse events
| Measure |
Placebo
Placebo
|
Duloxetine 60 mg
Duloxetine 60 mg
|
Duloxetine 90 mg
Duloxetine 90 mg
|
Duloxetine 120 mg
Duloxetine 120 mg
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
1.4%
2/142 • Number of events 2
|
1.6%
1/64 • Number of events 1
|
6.7%
3/45 • Number of events 3
|
0.00%
0/37
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
3/142 • Number of events 3
|
7.8%
5/64 • Number of events 7
|
0.00%
0/45
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
4/142 • Number of events 4
|
6.2%
4/64 • Number of events 5
|
2.2%
1/45 • Number of events 1
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
4.2%
6/142 • Number of events 6
|
4.7%
3/64 • Number of events 3
|
6.7%
3/45 • Number of events 3
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
10/142 • Number of events 12
|
4.7%
3/64 • Number of events 3
|
11.1%
5/45 • Number of events 7
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
6.3%
9/142 • Number of events 9
|
7.8%
5/64 • Number of events 5
|
24.4%
11/45 • Number of events 14
|
10.8%
4/37 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
4/142 • Number of events 5
|
3.1%
2/64 • Number of events 2
|
8.9%
4/45 • Number of events 4
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
7.0%
10/142 • Number of events 12
|
10.9%
7/64 • Number of events 8
|
11.1%
5/45 • Number of events 6
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.70%
1/142 • Number of events 1
|
0.00%
0/64
|
0.00%
0/45
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Fatigue
|
5.6%
8/142 • Number of events 8
|
6.2%
4/64 • Number of events 4
|
15.6%
7/45 • Number of events 9
|
10.8%
4/37 • Number of events 4
|
|
General disorders
Pain
|
1.4%
2/142 • Number of events 2
|
0.00%
0/64
|
6.7%
3/45 • Number of events 3
|
0.00%
0/37
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/142
|
1.6%
1/64 • Number of events 1
|
6.7%
3/45 • Number of events 4
|
0.00%
0/37
|
|
Immune system disorders
Seasonal allergy
|
0.70%
1/142 • Number of events 1
|
0.00%
0/64
|
0.00%
0/45
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
4.2%
6/142 • Number of events 8
|
3.1%
2/64 • Number of events 2
|
6.7%
3/45 • Number of events 3
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Influenza
|
10.6%
15/142 • Number of events 15
|
6.2%
4/64 • Number of events 4
|
4.4%
2/45 • Number of events 4
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
12.7%
18/142 • Number of events 26
|
15.6%
10/64 • Number of events 16
|
13.3%
6/45 • Number of events 8
|
8.1%
3/37 • Number of events 3
|
|
Investigations
Blood creatine phosphokinase increased
|
2.8%
4/142 • Number of events 4
|
0.00%
0/64
|
0.00%
0/45
|
5.4%
2/37 • Number of events 2
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/142
|
0.00%
0/64
|
2.2%
1/45 • Number of events 1
|
8.1%
3/37 • Number of events 3
|
|
Investigations
Weight increased
|
2.1%
3/142 • Number of events 3
|
3.1%
2/64 • Number of events 2
|
8.9%
4/45 • Number of events 4
|
2.7%
1/37 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.5%
5/142 • Number of events 7
|
1.6%
1/64 • Number of events 2
|
6.7%
3/45 • Number of events 7
|
8.1%
3/37 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.9%
14/142 • Number of events 14
|
12.5%
8/64 • Number of events 8
|
20.0%
9/45 • Number of events 10
|
13.5%
5/37 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.70%
1/142 • Number of events 1
|
0.00%
0/64
|
4.4%
2/45 • Number of events 2
|
5.4%
2/37 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.70%
1/142 • Number of events 1
|
3.1%
2/64 • Number of events 2
|
2.2%
1/45 • Number of events 1
|
5.4%
2/37 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
6/142 • Number of events 7
|
3.1%
2/64 • Number of events 2
|
4.4%
2/45 • Number of events 2
|
5.4%
2/37 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
8.5%
12/142 • Number of events 13
|
6.2%
4/64 • Number of events 4
|
4.4%
2/45 • Number of events 2
|
2.7%
1/37 • Number of events 1
|
|
Nervous system disorders
Headache
|
21.1%
30/142 • Number of events 35
|
32.8%
21/64 • Number of events 28
|
24.4%
11/45 • Number of events 14
|
8.1%
3/37 • Number of events 4
|
|
Nervous system disorders
Migraine
|
3.5%
5/142 • Number of events 6
|
3.1%
2/64 • Number of events 9
|
2.2%
1/45 • Number of events 1
|
5.4%
2/37 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
2.1%
3/142 • Number of events 3
|
1.6%
1/64 • Number of events 1
|
11.1%
5/45 • Number of events 7
|
2.7%
1/37 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
4.9%
7/142 • Number of events 11
|
1.6%
1/64 • Number of events 1
|
2.2%
1/45 • Number of events 2
|
8.1%
3/37 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
14.1%
20/142 • Number of events 22
|
6.2%
4/64 • Number of events 4
|
6.7%
3/45 • Number of events 3
|
5.4%
2/37 • Number of events 2
|
|
Renal and urinary disorders
Pollakiuria
|
2.8%
4/142 • Number of events 4
|
0.00%
0/64
|
0.00%
0/45
|
5.4%
2/37 • Number of events 2
|
|
Reproductive system and breast disorders
Ejaculation delayed
|
2.1%
3/142 • Number of events 3
|
1.6%
1/64 • Number of events 1
|
0.00%
0/45
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
2/142 • Number of events 2
|
0.00%
0/64
|
2.2%
1/45 • Number of events 1
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.5%
5/142 • Number of events 7
|
6.2%
4/64 • Number of events 5
|
0.00%
0/45
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
13.4%
19/142 • Number of events 19
|
7.8%
5/64 • Number of events 5
|
28.9%
13/45 • Number of events 13
|
13.5%
5/37 • Number of events 6
|
|
Vascular disorders
Hypertension
|
4.2%
6/142 • Number of events 6
|
1.6%
1/64 • Number of events 1
|
8.9%
4/45 • Number of events 4
|
2.7%
1/37 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60