Trial Outcomes & Findings for Duloxetine for Multiple Sclerosis Pain (NCT NCT00755807)
NCT ID: NCT00755807
Last Updated: 2011-12-09
Results Overview
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
239 participants
Primary outcome timeframe
Baseline, 6 weeks
Results posted on
2011-12-09
Participant Flow
Participant milestones
| Measure |
Duloxetine
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
|
Placebo
Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
|
|---|---|---|
|
Acute Phase
STARTED
|
118
|
121
|
|
Acute Phase
COMPLETED
|
100
|
109
|
|
Acute Phase
NOT COMPLETED
|
18
|
12
|
|
Open-label Extension Phase
STARTED
|
100
|
109
|
|
Open-label Extension Phase
COMPLETED
|
82
|
93
|
|
Open-label Extension Phase
NOT COMPLETED
|
18
|
16
|
Reasons for withdrawal
| Measure |
Duloxetine
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
|
Placebo
Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
|
|---|---|---|
|
Acute Phase
Adverse Event
|
16
|
5
|
|
Acute Phase
Protocol Violation
|
1
|
3
|
|
Acute Phase
Withdrawal by Subject
|
1
|
2
|
|
Acute Phase
Lack of Efficacy
|
0
|
1
|
|
Acute Phase
Physician Decision
|
0
|
1
|
|
Open-label Extension Phase
Adverse Event
|
7
|
7
|
|
Open-label Extension Phase
Protocol Violation
|
5
|
2
|
|
Open-label Extension Phase
Lack of Efficacy
|
3
|
3
|
|
Open-label Extension Phase
Withdrawal by Subject
|
1
|
3
|
|
Open-label Extension Phase
Lost to Follow-up
|
2
|
0
|
|
Open-label Extension Phase
Sponsor Decision
|
0
|
1
|
Baseline Characteristics
Duloxetine for Multiple Sclerosis Pain
Baseline characteristics by cohort
| Measure |
Duloxetine
n=118 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
|
Placebo
n=121 Participants
Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
50.77 years
STANDARD_DEVIATION 9.67 • n=5 Participants
|
52.67 years
STANDARD_DEVIATION 9.07 • n=7 Participants
|
51.73 years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
109 participants
n=5 Participants
|
112 participants
n=7 Participants
|
221 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=5 Participants
|
87 participants
n=7 Participants
|
174 participants
n=5 Participants
|
|
Multiple Sclerosis (MS) Diagnosis Subtype
Primary-Progressive
|
10 participants
n=5 Participants
|
16 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Multiple Sclerosis (MS) Diagnosis Subtype
Progressive-Relapsing
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Multiple Sclerosis (MS) Diagnosis Subtype
Relapsing-Remitting
|
81 participants
n=5 Participants
|
72 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Multiple Sclerosis (MS) Diagnosis Subtype
Secondary-Progressive
|
23 participants
n=5 Participants
|
27 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Duration of MS
|
11.05 years
STANDARD_DEVIATION 7.48 • n=5 Participants
|
11.40 years
STANDARD_DEVIATION 8.49 • n=7 Participants
|
11.23 years
STANDARD_DEVIATION 7.99 • n=5 Participants
|
|
Duration of central neuropathic pain (CNP) due to MS (n=118, 120)
|
6.18 years
STANDARD_DEVIATION 5.88 • n=5 Participants
|
7.56 years
STANDARD_DEVIATION 6.69 • n=7 Participants
|
6.88 years
STANDARD_DEVIATION 6.33 • n=5 Participants
|
|
Weekly 24-Hour Average Pain
|
6.49 units on a scale
STANDARD_DEVIATION 1.41 • n=5 Participants
|
6.31 units on a scale
STANDARD_DEVIATION 1.33 • n=7 Participants
|
6.40 units on a scale
STANDARD_DEVIATION 1.37 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Average Interference (Duloxetine n=116, Placebo n=119)
|
5.50 Units on a scale
STANDARD_DEVIATION 1.98 • n=5 Participants
|
5.24 Units on a scale
STANDARD_DEVIATION 2.01 • n=7 Participants
|
5.37 Units on a scale
STANDARD_DEVIATION 2.00 • n=5 Participants
|
|
BPI Average Pain (Duloxetine n=116, Placebo n=119)
|
6.09 units on a scale
STANDARD_DEVIATION 1.50 • n=5 Participants
|
5.91 units on a scale
STANDARD_DEVIATION 1.33 • n=7 Participants
|
6.00 units on a scale
STANDARD_DEVIATION 1.42 • n=5 Participants
|
|
Multiple Sclerosis Quality of Life (MS-QOL-54) Overall Quality of Life Subsection
|
58.06 units on a scale
STANDARD_DEVIATION 18.61 • n=5 Participants
|
61.78 units on a scale
STANDARD_DEVIATION 18.80 • n=7 Participants
|
59.94 units on a scale
STANDARD_DEVIATION 18.76 • n=5 Participants
|
|
Expanded Disability Status Scale ([EDSS], n=118, 120)
|
4.00 units on a scale
STANDARD_DEVIATION 2.01 • n=5 Participants
|
4.00 units on a scale
STANDARD_DEVIATION 1.78 • n=7 Participants
|
4.00 units on a scale
STANDARD_DEVIATION 1.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.
Outcome measures
| Measure |
Duloxetine
n=103 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=115 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)
|
-1.83 units on a scale
Standard Error 0.17
|
-1.07 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented for participants with early discontinuation. Baseline-observation-carried-forward (BOCF) imputation was implemented for participants with early discontinuation.
This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome (≥30% or ≥50% pain reduction from baseline) was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by participants in their diaries.
Outcome measures
| Measure |
Duloxetine
n=115 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=119 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)
≥30% Reduction (LOCF)
|
47 participants
|
32 participants
|
|
Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)
≥50% Reduction (LOCF)
|
26 participants
|
19 participants
|
|
Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)
≥30% Reduction (BOCF)
|
44 participants
|
29 participants
|
|
Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)
≥50% Reduction (BOCF)
|
24 participants
|
16 participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Number of randomized participants with at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented.
A scale that measures the participant'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). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.
Outcome measures
| Measure |
Duloxetine
n=106 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=116 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks
|
3.27 units on a scale
Standard Error 0.11
|
3.48 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst, least, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing pain interference in past 24 hours, such as general activity, mood, normal work, relations with other people, and sleep. Average interference=average of non-missing scores of individual interference items. Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.
Outcome measures
| Measure |
Duloxetine
n=106 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=116 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
BPI Severity for Worst Pain
|
-1.95 units on a scale
Standard Error 0.21
|
-1.29 units on a scale
Standard Error 0.20
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
BPI Severity for Least Pain
|
-1.20 units on a scale
Standard Error 0.18
|
-0.72 units on a scale
Standard Error 0.17
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
BPI Severity for Average Pain
|
-1.36 units on a scale
Standard Error 0.19
|
-0.84 units on a scale
Standard Error 0.17
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
BPI Severity for Pain Right Now
|
-1.91 units on a scale
Standard Error 0.21
|
-1.02 units on a scale
Standard Error 0.20
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
BPI Interference for General Activity
|
-1.81 units on a scale
Standard Error 0.23
|
-1.29 units on a scale
Standard Error 0.22
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
BPI Interference for Mood
|
-1.91 units on a scale
Standard Error 0.24
|
-1.25 units on a scale
Standard Error 0.22
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
BPI Interference for Walking Ability
|
-1.47 units on a scale
Standard Error 0.25
|
-0.91 units on a scale
Standard Error 0.24
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
BPI Interference for Normal Work
|
-1.51 units on a scale
Standard Error 0.24
|
-1.18 units on a scale
Standard Error 0.22
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
BPI Interference for Relations With Others
|
-1.72 units on a scale
Standard Error 0.22
|
-1.22 units on a scale
Standard Error 0.20
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
BPI Interference for Sleep
|
-2.01 units on a scale
Standard Error 0.22
|
-1.59 units on a scale
Standard Error 0.21
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
BPI Interference for Enjoyment Of Life
|
-1.82 units on a scale
Standard Error 0.24
|
-1.65 units on a scale
Standard Error 0.23
|
|
Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
BPI Mean Interference Score
|
-1.77 units on a scale
Standard Error 0.19
|
-1.32 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.
Outcome measures
| Measure |
Duloxetine
n=111 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=114 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)
|
-0.67 units on a scale
Standard Error 0.09
|
-0.44 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.
Outcome measures
| Measure |
Duloxetine
n=106 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=116 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Physical Health Composite (N=106, 116)
|
6.11 units on a scale
Standard Error 1.15
|
5.12 units on a scale
Standard Error 1.08
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Mental Health Composite (N=106, 116)
|
5.81 units on a scale
Standard Error 1.44
|
4.59 units on a scale
Standard Error 1.35
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Physical Health (N=106, 116)
|
3.35 units on a scale
Standard Error 1.51
|
2.65 units on a scale
Standard Error 1.42
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Health Perceptions (N=106, 116)
|
1.41 units on a scale
Standard Error 1.39
|
1.35 units on a scale
Standard Error 1.31
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Energy Subsection Score (N=106, 116)
|
6.54 units on a scale
Standard Error 1.60
|
6.51 units on a scale
Standard Error 1.50
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Role Limitation Due to Physical (N=106, 116)
|
11.73 units on a scale
Standard Error 3.17
|
8.60 units on a scale
Standard Error 2.97
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Pain (N=106, 116)
|
12.42 units on a scale
Standard Error 1.72
|
8.84 units on a scale
Standard Error 1.62
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Sexual Function (N=106, 116)
|
1.30 units on a scale
Standard Error 2.21
|
1.12 units on a scale
Standard Error 2.09
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Social Function (N=106, 116)
|
5.02 units on a scale
Standard Error 1.71
|
6.97 units on a scale
Standard Error 1.61
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Health Distress (N=106, 116)
|
8.96 units on a scale
Standard Error 1.76
|
9.34 units on a scale
Standard Error 1.66
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Overall Quality Of Life (N=106, 116)
|
3.66 units on a scale
Standard Error 1.34
|
5.43 units on a scale
Standard Error 1.26
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Emotional Well-being Subsection Score (N=106, 116)
|
4.59 units on a scale
Standard Error 1.37
|
3.99 units on a scale
Standard Error 1.29
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Role Limitation Due to Emotional (N=106, 116)
|
6.48 units on a scale
Standard Error 3.55
|
1.58 units on a scale
Standard Error 3.33
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Cognitive Function (N=106, 116)
|
6.38 units on a scale
Standard Error 1.45
|
5.57 units on a scale
Standard Error 1.36
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Change in Health (N=106, 116)
|
8.23 units on a scale
Standard Error 2.30
|
6.25 units on a scale
Standard Error 2.16
|
|
Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
Satisfaction with Sexual Function (N=102, 112)
|
2.66 units on a scale
Standard Error 2.82
|
-1.35 units on a scale
Standard Error 2.68
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All randomized participants.
C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a "yes" answer to actual attempt or completed suicide.
Outcome measures
| Measure |
Duloxetine
n=118 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=121 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6
Suicidal Ideation
|
3 participants
|
0 participants
|
|
Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6
Suicidal Behavior
|
1 participants
|
0 participants
|
|
Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6
Suicidal Acts
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.
Outcome measures
| Measure |
Duloxetine
n=115 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=119 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase)
|
-1.25 units on a scale
Standard Error 0.12
|
-0.74 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with a score ranging from 0 to 3.
Outcome measures
| Measure |
Duloxetine
n=105 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=115 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase)
|
-0.04 units on a scale
Standard Deviation 0.39
|
-0.03 units on a scale
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: All randomized participants.
Outcome measures
| Measure |
Duloxetine
n=118 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=121 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Number of Participants Who Discontinued During the Acute Phase (by Week 6)
Discontinued Due to Any Reason
|
18 participants
|
12 participants
|
|
Number of Participants Who Discontinued During the Acute Phase (by Week 6)
Adverse Event (AE)
|
16 participants
|
5 participants
|
|
Number of Participants Who Discontinued During the Acute Phase (by Week 6)
Protocol Violation
|
1 participants
|
3 participants
|
|
Number of Participants Who Discontinued During the Acute Phase (by Week 6)
Subject Decision
|
1 participants
|
2 participants
|
|
Number of Participants Who Discontinued During the Acute Phase (by Week 6)
Lack of Efficacy
|
0 participants
|
1 participants
|
|
Number of Participants Who Discontinued During the Acute Phase (by Week 6)
Physician Decision
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: All randomized participants.
Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.
Outcome measures
| Measure |
Duloxetine
n=118 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=121 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase
Adverse Events (AEs) - Any Event
|
70 participants
|
59 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase
Serious Adverse Events (SAEs) - Any Event
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: All randomized participants.
Outcome measures
| Measure |
Duloxetine
n=118 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=121 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Feeling jittery
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Any Adverse Event (AE)
|
16 participants
|
5 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Dizziness
|
3 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Somnolence
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Abdominal discomfort
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Asthenia
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Back pain
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Balance disorder
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Fear
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Headache
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Hypotension
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Libido decreased
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Mood altered
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Nausea
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Pain in extremity
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Rash maculo-papular
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Suicide attempt
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
Throat irritation
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
Outcome measures
| Measure |
Duloxetine
n=112 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=119 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Blood Pressure at Week 6 (Acute Phase)
Diastolic Blood Pressure
|
1.34 mm Hg
Standard Error 0.66
|
0.48 mm Hg
Standard Error 0.63
|
|
Change From Baseline in Blood Pressure at Week 6 (Acute Phase)
Systolic Blood Pressure
|
0.34 mm Hg
Standard Error 1.14
|
-0.06 mm Hg
Standard Error 1.09
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
Outcome measures
| Measure |
Duloxetine
n=112 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=118 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Pulse Rate at Week 6 (Acute Phase)
|
1.76 beats per minute (bpm)
Standard Error 0.84
|
0.22 beats per minute (bpm)
Standard Error 0.81
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
Outcome measures
| Measure |
Duloxetine
n=99 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=115 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Weight at Week 6 (Acute Phase)
|
-0.69 kilograms (kg)
Standard Error 0.20
|
0.08 kilograms (kg)
Standard Error 0.18
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: Number of randomized participants who entered and had at least 1 non-missing value during extension phase.
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The scores range from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Duloxetine
n=204 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks
|
2.67 units on a scale
Standard Deviation 1.25
|
—
|
SECONDARY outcome
Timeframe: Baseline (end of acute phase/Week 6), Endpoint (Week 18)Population: Number of randomized participants who entered and had at least 1 non-missing value during extension phase.
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.
Outcome measures
| Measure |
Duloxetine
n=201 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
BPI-S for Worst Pain
|
-1.27 units on a scale
Standard Deviation 2.07
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
BPI-S for Pain Right Now
|
-1.03 units on a scale
Standard Deviation 2.20
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
BPI-I for Mood
|
-1.08 units on a scale
Standard Deviation 2.56
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
BPI-S for Least Pain
|
-0.96 units on a scale
Standard Deviation 1.84
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
BPI-S for Average Pain
|
-1.26 units on a scale
Standard Deviation 1.76
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
BPI-I for General Activity
|
-1.01 units on a scale
Standard Deviation 2.50
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
BPI-I for Walking Ability
|
-0.84 units on a scale
Standard Deviation 2.62
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
BPI-I for Normal Work
|
-1.00 units on a scale
Standard Deviation 2.60
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
BPI-I for Relations With Others
|
-0.65 units on a scale
Standard Deviation 2.59
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
BPI-I for Sleep
|
-0.70 units on a scale
Standard Deviation 2.37
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
BPI-I for Enjoyment Of Life
|
-1.03 units on a scale
Standard Deviation 2.47
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
BPI for Mean Interference Score
|
-0.89 units on a scale
Standard Deviation 2.06
|
—
|
SECONDARY outcome
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)Population: Number of randomized participants who entered and had at least 1 non-missing value during extension phase.
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Outcome measures
| Measure |
Duloxetine
n=206 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase)
|
-0.59 units on a scale
Standard Deviation 1.02
|
—
|
SECONDARY outcome
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)Population: Number of randomized participants who entered and had at least 1 non-missing value during extension phase.
A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress.
Outcome measures
| Measure |
Duloxetine
n=201 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Physical Health Composite Section Score (N=198)
|
2.70 units on a scale
Standard Deviation 12.32
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Mental Health Composite Section Score (N=201)
|
1.97 units on a scale
Standard Deviation 14.45
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Physical Health Subsection Score (N=201)
|
3.16 units on a scale
Standard Deviation 14.29
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Health Perceptions Subsection Score (N=201)
|
2.24 units on a scale
Standard Deviation 14.04
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Energy Subsection Score (N=201)
|
2.93 units on a scale
Standard Deviation 15.42
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Role Limitation Due to Physical Problems (N=201)
|
0.50 units on a scale
Standard Deviation 39.29
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Pain Subsection Score (N=201)
|
7.45 units on a scale
Standard Deviation 17.57
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Sexual Function Subsection Score (N=198)
|
0.79 units on a scale
Standard Deviation 23.38
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Social Function Subsection Score (N=201)
|
2.53 units on a scale
Standard Deviation 18.30
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Health Distress Subsection Score (N=201)
|
1.44 units on a scale
Standard Deviation 18.51
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Overall Quality Of Life Subsection Score (N=201)
|
1.47 units on a scale
Standard Deviation 11.04
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Emotional Well-being Subsection Score (N=201)
|
2.63 units on a scale
Standard Deviation 13.61
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Role Limitation Due to Emotional Problems (N=201)
|
3.15 units on a scale
Standard Deviation 38.96
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Cognitive Function Subsection Score (N=201)
|
-0.07 units on a scale
Standard Deviation 14.64
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Change in Health Subsection Score (N=201)
|
4.35 units on a scale
Standard Deviation 25.30
|
—
|
|
Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
Satisfaction with Sexual Function Subsect (N=195)
|
1.92 units on a scale
Standard Deviation 30.56
|
—
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: All randomized participants who entered the extension phase.
C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a "yes" answer to actual attempt or completed suicide.
Outcome measures
| Measure |
Duloxetine
n=209 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18
Suicidal Ideation
|
1 participants
|
—
|
|
Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18
Suicidal Behavior
|
0 participants
|
—
|
|
Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18
Suicidal Acts
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (6 weeks) through Endpoint (18 weeks)Population: Number of randomized participants who entered and had at least 1 non-missing value during extension phase.
Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. Each weekly mean change represents change relative to week 6, the baseline of the extension phase.
Outcome measures
| Measure |
Duloxetine
n=206 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
Week 7 (n=185)
|
-0.05 units on a scale
Standard Error 0.07
|
—
|
|
Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
Week 8 (n=205)
|
-0.31 units on a scale
Standard Error 0.07
|
—
|
|
Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
Week 9 (n=184)
|
-0.54 units on a scale
Standard Error 0.08
|
—
|
|
Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
Week 10 (n=197)
|
-0.62 units on a scale
Standard Error 0.08
|
—
|
|
Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
Week 11 (n=166)
|
-0.75 units on a scale
Standard Error 0.08
|
—
|
|
Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
Week 12 (n=192)
|
-0.89 units on a scale
Standard Error 0.09
|
—
|
|
Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
Week 13 (n=166)
|
-1.05 units on a scale
Standard Error 0.09
|
—
|
|
Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
Week 14 (n=177)
|
-0.98 units on a scale
Standard Error 0.10
|
—
|
|
Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
Week 15 (n=158)
|
-0.99 units on a scale
Standard Error 0.11
|
—
|
|
Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
Week 16 (n=176)
|
-1.04 units on a scale
Standard Error 0.11
|
—
|
|
Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
Week 17 (n=156)
|
-1.11 units on a scale
Standard Error 0.11
|
—
|
|
Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
Week 18 (n=175)
|
-1.04 units on a scale
Standard Error 0.11
|
—
|
SECONDARY outcome
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)Population: Number of randomized participants who entered and had at least 1 non-missing value during extension phase.
The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with the score ranging from 0 to 3.
Outcome measures
| Measure |
Duloxetine
n=200 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase)
|
-0.01 units on a scale
Standard Deviation 0.19
|
—
|
SECONDARY outcome
Timeframe: Baseline (6 weeks) through Endpoint (18 weeks)Population: All participants randomized to placebo in acute phase received duloxetine during the extension phase.
Outcome measures
| Measure |
Duloxetine
n=209 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)
Discontinued Due to Any Reason
|
34 participants
|
—
|
|
Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)
Adverse Event
|
14 participants
|
—
|
|
Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)
Protocol Violation
|
7 participants
|
—
|
|
Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)
Lack of Efficacy
|
6 participants
|
—
|
|
Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)
Subject Decision
|
4 participants
|
—
|
|
Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)
Lost to follow up
|
2 participants
|
—
|
|
Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)
Sponsor Decision
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (6 weeks) through Endpoint (18 weeks)Population: All randomized participants in the open-label extension phase.
Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.
Outcome measures
| Measure |
Duloxetine
n=209 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase
Adverse Events (AEs) - Any Event
|
130 participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase
Serious Adverse Events (SAEs) - Any Event
|
7 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (6 weeks) through Endpoint (18 weeks)Population: All randomized participants in the open-label extension phase.
Outcome measures
| Measure |
Duloxetine
n=209 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Due to any AE
|
14 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Fatigue
|
2 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Somnolence
|
2 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Alanine aminotransferase increased
|
1 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Constipation
|
1 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Diverticulitis
|
1 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Dizziness
|
1 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Fall
|
1 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Hypertension
|
1 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Insomnia
|
1 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Multiple sclerosis relapse
|
1 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Nausea
|
1 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
Rash pruritic
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)Population: Number of randomized participants who entered and had at least 1 non-missing value during extension phase.
Outcome measures
| Measure |
Duloxetine
n=207 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase)
Diastolic
|
-0.58 mm Hg
Standard Deviation 8.44
|
—
|
|
Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase)
Systolic
|
-1.22 mm Hg
Standard Deviation 13.07
|
—
|
SECONDARY outcome
Timeframe: Baseline (6 weeks), endpoint (18 weeks)Population: Number of randomized participants who entered and had at least 1 non-missing value during extension phase.
Outcome measures
| Measure |
Duloxetine
n=207 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase)
|
1.47 beats per minute (bpm)
Standard Deviation 9.81
|
—
|
SECONDARY outcome
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)Population: Number of randomized participants who entered and had at least 1 non-missing value during extension phase.
Outcome measures
| Measure |
Duloxetine
n=190 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Weight at Week 18 (Open-label Extension Phase)
|
-0.30 kilograms (kg)
Standard Deviation 2.84
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
Change from baseline to acute phase endpoint in laboratory assessment for bicarbonate, HCO3.
Outcome measures
| Measure |
Duloxetine
n=110 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=116 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Bicarbonate (HCO3) at Week 6 (Acute Phase)
Baseline
|
22.43 milliEq/Liter
Standard Deviation 3.01
|
23.23 milliEq/Liter
Standard Deviation 2.81
|
|
Change From Baseline in Bicarbonate (HCO3) at Week 6 (Acute Phase)
Change to Last Observation
|
2.08 milliEq/Liter
Standard Deviation 2.91
|
1.38 milliEq/Liter
Standard Deviation 2.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
Change from baseline to acute phase endpoint in laboratory assessment of creatinine.
Outcome measures
| Measure |
Duloxetine
n=109 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=116 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Creatinine at Week 6 (Acute Phase)
Baseline
|
0.79 milligram/deciliter (mg/dL)
Standard Deviation 0.15
|
0.78 milligram/deciliter (mg/dL)
Standard Deviation 0.17
|
|
Change From Baseline in Creatinine at Week 6 (Acute Phase)
Change to Last Observation
|
-0.00 milligram/deciliter (mg/dL)
Standard Deviation 0.20
|
0.01 milligram/deciliter (mg/dL)
Standard Deviation 0.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
Change from baseline to acute phase endpoint in laboratory assessment of platelet count.
Outcome measures
| Measure |
Duloxetine
n=106 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=113 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in the Platelet Count at Week 6 (Acute Phase)
Baseline
|
266.92 Thousand/microliter
Standard Deviation 77.19
|
281.22 Thousand/microliter
Standard Deviation 66.78
|
|
Change From Baseline in the Platelet Count at Week 6 (Acute Phase)
Change to Last Observation
|
-2.20 Thousand/microliter
Standard Deviation 43.10
|
-11.00 Thousand/microliter
Standard Deviation 40.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
Change from baseline to acute phase endpoint in laboratory assessment of inorganic phosphorus.
Outcome measures
| Measure |
Duloxetine
n=109 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=116 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Inorganic Phosphorus at Week 6 (Acute Phase)
Baseline
|
3.63 mg/dL
Standard Deviation 0.60
|
3.68 mg/dL
Standard Deviation 0.54
|
|
Change From Baseline in Inorganic Phosphorus at Week 6 (Acute Phase)
Change to Last Observation
|
-0.17 mg/dL
Standard Deviation 0.50
|
0.01 mg/dL
Standard Deviation 0.56
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeksPopulation: Number of randomized participants with baseline and at least 1 post-baseline value.
Change from baseline to acute phase endpoint in laboratory assessment of uric acid.
Outcome measures
| Measure |
Duloxetine
n=110 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
n=116 Participants
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Uric Acid at Week 6 (Acute Phase)
Baseline
|
5.19 mg/dL
Standard Deviation 1.58
|
4.74 mg/dL
Standard Deviation 1.30
|
|
Change From Baseline in Uric Acid at Week 6 (Acute Phase)
Change to Last Observation
|
-0.23 mg/dL
Standard Deviation 0.67
|
-0.04 mg/dL
Standard Deviation 0.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)Population: Number of randomized participants who entered and had at least 1 non-missing value during extension phase.
Outcome measures
| Measure |
Duloxetine
n=198 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Monocytes at Week 18 (Open-label Extension Phase)
Baseline
|
0.38 Thousand/microliter
Standard Deviation 0.14
|
—
|
|
Change From Baseline in Monocytes at Week 18 (Open-label Extension Phase)
Change to Last Observation
|
0.02 Thousand/microliter
Standard Deviation 0.14
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)Population: Number of randomized participants who entered and had at least 1 non-missing value during extension phase.
Outcome measures
| Measure |
Duloxetine
n=201 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Sodium at Week 18 (Open-label Extension Phase)
Baseline
|
140.08 milliEq/Liter
Standard Deviation 3.04
|
—
|
|
Change From Baseline in Sodium at Week 18 (Open-label Extension Phase)
Change to Last Observation
|
-0.36 milliEq/Liter
Standard Deviation 2.76
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (6 weeks), Endpoint (18 weeks)Population: Number of randomized participants who entered and had at least 1 non-missing value during extension phase.
Outcome measures
| Measure |
Duloxetine
n=202 Participants
Participants received 30 milligrams (mg) duloxetine (oral \[po\], once daily \[QD\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
|
Placebo
Participants received placebo (po, QD) for 6 weeks (acute phase).
|
|---|---|---|
|
Change From Baseline in Total Protein at Week 18 (Open-label Extension Phase)
Baseline
|
7.04 gram/deciliter (g/dL)
Standard Deviation 0.43
|
—
|
|
Change From Baseline in Total Protein at Week 18 (Open-label Extension Phase)
Change to Last Observation
|
-0.06 gram/deciliter (g/dL)
Standard Deviation 0.36
|
—
|
Adverse Events
Duloxetine - Double-Blind Acute Phase
Serious events: 4 serious events
Other events: 70 other events
Deaths: 0 deaths
Placebo - Double-Blind Acute Phase
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Duloxetine - Open-label Extension Phase
Serious events: 7 serious events
Other events: 130 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duloxetine - Double-Blind Acute Phase
n=118 participants at risk
60 mg oral (po), once daily (QD) for 6 weeks (acute phase)
|
Placebo - Double-Blind Acute Phase
n=121 participants at risk
Oral, QD for 6 weeks
|
Duloxetine - Open-label Extension Phase
n=209 participants at risk
Participants previously receiving duloxetine or placebo in the double-blind acute phase received duloxetine 60, 90, or 120 mg QD for 12 weeks (open label extension phase)
|
|---|---|---|---|
|
Infections and infestations
Cystitis
|
0.85%
1/118 • Number of events 1
|
0.00%
0/121
|
0.00%
0/209
|
|
Infections and infestations
Pneumonia
|
0.00%
0/118
|
0.00%
0/121
|
0.48%
1/209 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/118
|
0.00%
0/121
|
0.48%
1/209 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.85%
1/118 • Number of events 1
|
0.00%
0/121
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.85%
1/118 • Number of events 1
|
0.00%
0/121
|
0.00%
0/209
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/118
|
0.00%
0/121
|
0.48%
1/209 • Number of events 1
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/118
|
0.00%
0/121
|
0.96%
2/209 • Number of events 2
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/118
|
0.00%
0/121
|
0.48%
1/209 • Number of events 1
|
|
Psychiatric disorders
Suicide attempt
|
0.85%
1/118 • Number of events 1
|
0.00%
0/121
|
0.00%
0/209
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/118
|
0.00%
0/121
|
0.48%
1/209 • Number of events 1
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/118
|
0.00%
0/121
|
0.48%
1/209 • Number of events 1
|
Other adverse events
| Measure |
Duloxetine - Double-Blind Acute Phase
n=118 participants at risk
60 mg oral (po), once daily (QD) for 6 weeks (acute phase)
|
Placebo - Double-Blind Acute Phase
n=121 participants at risk
Oral, QD for 6 weeks
|
Duloxetine - Open-label Extension Phase
n=209 participants at risk
Participants previously receiving duloxetine or placebo in the double-blind acute phase received duloxetine 60, 90, or 120 mg QD for 12 weeks (open label extension phase)
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/118
|
1.7%
2/121 • Number of events 2
|
0.48%
1/209 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.85%
1/118 • Number of events 1
|
0.00%
0/121
|
1.9%
4/209 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.5%
3/118 • Number of events 3
|
1.7%
2/121 • Number of events 2
|
0.00%
0/209
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/118
|
0.00%
0/121
|
1.4%
3/209 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
2/118 • Number of events 2
|
0.83%
1/121 • Number of events 1
|
0.48%
1/209 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
5.9%
7/118 • Number of events 7
|
4.1%
5/121 • Number of events 5
|
1.4%
3/209 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
5/118 • Number of events 5
|
1.7%
2/121 • Number of events 2
|
3.3%
7/209 • Number of events 7
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
7/118 • Number of events 7
|
2.5%
3/121 • Number of events 3
|
2.4%
5/209 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
7.6%
9/118 • Number of events 10
|
5.8%
7/121 • Number of events 7
|
4.3%
9/209 • Number of events 10
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
3/118 • Number of events 3
|
0.00%
0/121
|
2.4%
5/209 • Number of events 5
|
|
General disorders
Fatigue
|
7.6%
9/118 • Number of events 9
|
5.8%
7/121 • Number of events 7
|
6.7%
14/209 • Number of events 15
|
|
General disorders
Feeling jittery
|
0.85%
1/118 • Number of events 1
|
1.7%
2/121 • Number of events 2
|
0.00%
0/209
|
|
General disorders
Oedema peripheral
|
0.85%
1/118 • Number of events 1
|
0.00%
0/121
|
2.4%
5/209 • Number of events 6
|
|
General disorders
Pyrexia
|
0.00%
0/118
|
2.5%
3/121 • Number of events 3
|
0.48%
1/209 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/118
|
2.5%
3/121 • Number of events 3
|
0.48%
1/209 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
1.7%
2/118 • Number of events 2
|
0.00%
0/121
|
1.9%
4/209 • Number of events 4
|
|
Infections and infestations
Influenza
|
1.7%
2/118 • Number of events 2
|
0.00%
0/121
|
0.96%
2/209 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
0.85%
1/118 • Number of events 1
|
1.7%
2/121 • Number of events 2
|
2.4%
5/209 • Number of events 5
|
|
Infections and infestations
Sinusitis
|
0.00%
0/118
|
1.7%
2/121 • Number of events 2
|
1.9%
4/209 • Number of events 4
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
3/118 • Number of events 3
|
1.7%
2/121 • Number of events 2
|
2.9%
6/209 • Number of events 6
|
|
Infections and infestations
Urinary tract infection
|
0.85%
1/118 • Number of events 1
|
2.5%
3/121 • Number of events 3
|
2.9%
6/209 • Number of events 6
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/118
|
0.83%
1/121 • Number of events 1
|
1.4%
3/209 • Number of events 4
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
2/118 • Number of events 3
|
0.83%
1/121 • Number of events 1
|
3.3%
7/209 • Number of events 12
|
|
Investigations
Heart rate increased
|
0.00%
0/118
|
0.00%
0/121
|
1.9%
4/209 • Number of events 5
|
|
Investigations
Weight decreased
|
3.4%
4/118 • Number of events 4
|
0.00%
0/121
|
0.48%
1/209 • Number of events 1
|
|
Investigations
Weight increased
|
0.85%
1/118 • Number of events 1
|
0.83%
1/121 • Number of events 1
|
1.4%
3/209 • Number of events 3
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.9%
7/118 • Number of events 7
|
0.00%
0/121
|
1.4%
3/209 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/121
|
2.9%
6/209 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.85%
1/118 • Number of events 1
|
1.7%
2/121 • Number of events 2
|
1.4%
3/209 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.85%
1/118 • Number of events 1
|
0.00%
0/121
|
1.4%
3/209 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
4/118 • Number of events 5
|
0.83%
1/121 • Number of events 1
|
1.9%
4/209 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/118
|
0.83%
1/121 • Number of events 1
|
1.4%
3/209 • Number of events 3
|
|
Nervous system disorders
Balance disorder
|
3.4%
4/118 • Number of events 4
|
1.7%
2/121 • Number of events 2
|
0.48%
1/209 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
7.6%
9/118 • Number of events 10
|
4.1%
5/121 • Number of events 5
|
1.9%
4/209 • Number of events 4
|
|
Nervous system disorders
Headache
|
4.2%
5/118 • Number of events 5
|
5.0%
6/121 • Number of events 6
|
3.3%
7/209 • Number of events 7
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/118
|
1.7%
2/121 • Number of events 2
|
2.9%
6/209 • Number of events 6
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/118
|
0.83%
1/121 • Number of events 1
|
1.9%
4/209 • Number of events 4
|
|
Nervous system disorders
Somnolence
|
5.1%
6/118 • Number of events 6
|
2.5%
3/121 • Number of events 3
|
2.9%
6/209 • Number of events 6
|
|
Nervous system disorders
Tremor
|
0.85%
1/118 • Number of events 2
|
0.00%
0/121
|
1.4%
3/209 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
0.85%
1/118 • Number of events 1
|
0.00%
0/121
|
1.4%
3/209 • Number of events 3
|
|
Psychiatric disorders
Depression
|
0.85%
1/118 • Number of events 1
|
1.7%
2/121 • Number of events 2
|
0.00%
0/209
|
|
Psychiatric disorders
Insomnia
|
3.4%
4/118 • Number of events 4
|
0.83%
1/121 • Number of events 1
|
1.9%
4/209 • Number of events 4
|
|
Psychiatric disorders
Libido decreased
|
2.5%
3/118 • Number of events 3
|
2.5%
3/121 • Number of events 3
|
0.48%
1/209 • Number of events 1
|
|
Psychiatric disorders
Thinking abnormal
|
1.7%
2/118 • Number of events 2
|
0.00%
0/121
|
0.00%
0/209
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/118
|
0.00%
0/121
|
1.4%
3/209 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/118
|
1.7%
2/121 • Number of events 2
|
0.96%
2/209 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.7%
2/118 • Number of events 3
|
0.00%
0/121
|
0.00%
0/209
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.7%
2/118 • Number of events 2
|
0.00%
0/121
|
1.4%
3/209 • Number of events 4
|
|
Vascular disorders
Hypertension
|
0.85%
1/118 • Number of events 1
|
1.7%
2/121 • Number of events 2
|
0.48%
1/209 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60