Trial Outcomes & Findings for Duloxetine Versus Placebo in Chronic Low Back Pain (NCT NCT00424593)
NCT ID: NCT00424593
Last Updated: 2009-11-20
Results Overview
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
236 participants
Primary outcome timeframe
Baseline, Week 13
Results posted on
2009-11-20
Participant Flow
Participant milestones
| Measure |
Duloxetine
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Acute Double-Blind Period
STARTED
|
115
|
121
|
|
Acute Double-Blind Period
COMPLETED
|
84
|
98
|
|
Acute Double-Blind Period
NOT COMPLETED
|
31
|
23
|
|
Dose-Blind Extension Period
STARTED
|
181
|
0
|
|
Dose-Blind Extension Period
COMPLETED
|
117
|
0
|
|
Dose-Blind Extension Period
NOT COMPLETED
|
64
|
0
|
Reasons for withdrawal
| Measure |
Duloxetine
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Acute Double-Blind Period
Adverse Event
|
16
|
7
|
|
Acute Double-Blind Period
Withdrawal by Subject
|
11
|
10
|
|
Acute Double-Blind Period
Protocol Violation
|
2
|
2
|
|
Acute Double-Blind Period
Physician Decision
|
1
|
2
|
|
Acute Double-Blind Period
Lost to Follow-up
|
1
|
1
|
|
Acute Double-Blind Period
Lack of Efficacy
|
0
|
1
|
|
Dose-Blind Extension Period
Withdrawal by Subject
|
19
|
0
|
|
Dose-Blind Extension Period
Adverse Event
|
18
|
0
|
|
Dose-Blind Extension Period
Lack of Efficacy
|
9
|
0
|
|
Dose-Blind Extension Period
Protocol Violation
|
9
|
0
|
|
Dose-Blind Extension Period
Lost to Follow-up
|
6
|
0
|
|
Dose-Blind Extension Period
Physician Decision
|
3
|
0
|
Baseline Characteristics
Duloxetine Versus Placebo in Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Duloxetine
n=115 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=121 Participants
every day (QD), by mouth (PO), 13 weeks
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
51.81 years
STANDARD_DEVIATION 14.92 • n=5 Participants
|
51.15 years
STANDARD_DEVIATION 13.46 • n=7 Participants
|
51.47 years
STANDARD_DEVIATION 14.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
25 participants
n=5 Participants
|
29 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
19 participants
n=5 Participants
|
25 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
37 participants
n=5 Participants
|
35 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Race/Ethnicity
African
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
85 participants
n=5 Participants
|
91 participants
n=7 Participants
|
176 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Race/Ethnicity
Native American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.63 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.42 • n=5 Participants
|
27.03 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.81 • n=7 Participants
|
27.33 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.12 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Average Pain Score
|
5.91 units on a scale
STANDARD_DEVIATION 1.59 • n=5 Participants
|
5.96 units on a scale
STANDARD_DEVIATION 1.66 • n=7 Participants
|
5.94 units on a scale
STANDARD_DEVIATION 1.62 • n=5 Participants
|
|
Duration of Chronic Lower Back Pain Since Onset
|
8.79 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
9.54 years
STANDARD_DEVIATION 8.60 • n=7 Participants
|
9.18 years
STANDARD_DEVIATION 8.66 • n=5 Participants
|
|
Height
|
165.92 centimeters (cm)
STANDARD_DEVIATION 10.39 • n=5 Participants
|
167.40 centimeters (cm)
STANDARD_DEVIATION 11.34 • n=7 Participants
|
166.68 centimeters (cm)
STANDARD_DEVIATION 10.89 • n=5 Participants
|
|
Weight
|
76.24 kilograms (kg)
STANDARD_DEVIATION 14.71 • n=5 Participants
|
75.89 kilograms (kg)
STANDARD_DEVIATION 13.94 • n=7 Participants
|
76.06 kilograms (kg)
STANDARD_DEVIATION 14.29 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 13Population: Number of participants with baseline and at least one non-missing post-baseline value.
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Duloxetine
n=109 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=115 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores
|
-2.32 units on a scale
Standard Error 0.22
|
-1.50 units on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Week 13Population: Number of participants with at least one non-missing post-baseline value. Last observation carried forward.
A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Duloxetine
n=107 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=115 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Patient's Global Impression of Improvement (PGI-I)
|
2.81 units on a scale
Standard Deviation 1.18
|
3.23 units on a scale
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Baseline, Week 13, Week 54Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.
Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Outcome measures
| Measure |
Duloxetine
n=99 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=105 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score
13 Week Baseline
|
10.39 units on a scale
Standard Deviation 4.78
|
10.87 units on a scale
Standard Deviation 5.12
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score
13 Week Change from Baseline
|
-3.13 units on a scale
Standard Deviation 4.65
|
-1.53 units on a scale
Standard Deviation 4.85
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score
54 Week Baseline (n=59, n=82)
|
7.83 units on a scale
Standard Deviation 5.75
|
9.59 units on a scale
Standard Deviation 6.11
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score
54 Week Change from Baseline (n=59, n=82)
|
-1.14 units on a scale
Standard Deviation 3.51
|
-2.40 units on a scale
Standard Deviation 5.30
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of randomized participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.
24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items.
Outcome measures
| Measure |
Duloxetine
n=111 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=116 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale
Average Pain Score Baseline
|
5.94 units on a scale
Standard Deviation 1.36
|
6.05 units on a scale
Standard Deviation 1.33
|
|
Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale
Worst Pain Score Baseline
|
6.91 units on a scale
Standard Deviation 1.24
|
7.02 units on a scale
Standard Deviation 1.21
|
|
Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale
Worst Pain Score Change from Baseline
|
-1.97 units on a scale
Standard Deviation 2.01
|
-1.31 units on a scale
Standard Deviation 1.89
|
|
Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale
Average Pain Score Change from Baseline
|
-1.92 units on a scale
Standard Deviation 1.91
|
-1.16 units on a scale
Standard Deviation 1.95
|
|
Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale
Night Pain Score Baseline
|
5.46 units on a scale
Standard Deviation 1.77
|
5.50 units on a scale
Standard Deviation 1.81
|
|
Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale
Night Pain Score Change from Baseline
|
-1.82 units on a scale
Standard Deviation 2.01
|
-1.15 units on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Baseline, Week 13, Week 54Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.
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=109 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=115 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Worst Pain Score Week 13 Baseline
|
7.43 units on a scale
Standard Deviation 1.34
|
7.34 units on a scale
Standard Deviation 1.46
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Worst Pain Score Week 13 Change from Baseline
|
-2.55 units on a scale
Standard Deviation 2.31
|
-1.72 units on a scale
Standard Deviation 2.25
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Worst Pain Score Week 54 Baseline (n=80, n=97)
|
4.49 units on a scale
Standard Deviation 2.14
|
5.67 units on a scale
Standard Deviation 2.38
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Worst Pain Score Week 54 Change from Baseline
|
-1.31 units on a scale
Standard Deviation 2.43
|
-1.78 units on a scale
Standard Deviation 2.56
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Least Pain Score Week 13 Baseline
|
4.22 units on a scale
Standard Deviation 2.33
|
4.22 units on a scale
Standard Deviation 2.42
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Least Pain Score Week 13 Change from Baseline
|
-1.72 units on a scale
Standard Deviation 2.05
|
-0.83 units on a scale
Standard Deviation 2.16
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Least Pain Score Week 54 Baseline (n=80, n=97)
|
2.36 units on a scale
Standard Deviation 1.98
|
3.33 units on a scale
Standard Deviation 2.60
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Least Pain Score Week 54 Change from Baseline
|
-0.81 units on a scale
Standard Deviation 1.67
|
-0.93 units on a scale
Standard Deviation 2.21
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Average Pain Score Week 13 Baseline
|
5.91 units on a scale
Standard Deviation 1.61
|
5.93 units on a scale
Standard Deviation 1.67
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Average Pain Score Week 13 Change from Baseline
|
-2.08 units on a scale
Standard Deviation 2.14
|
-1.43 units on a scale
Standard Deviation 2.25
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Average Pain Score Week 54 Baseline (n=80, n=97)
|
3.40 units on a scale
Standard Deviation 1.87
|
4.45 units on a scale
Standard Deviation 2.29
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Average Pain Score Week 54 Change from Baseline
|
-1.05 units on a scale
Standard Deviation 1.79
|
-1.35 units on a scale
Standard Deviation 2.24
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Pain Right Now Score Week 13 Baseline
|
5.42 units on a scale
Standard Deviation 2.12
|
5.55 units on a scale
Standard Deviation 2.05
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Pain Right Now Score Week 13 Change from Baseline
|
-2.29 units on a scale
Standard Deviation 2.41
|
-1.43 units on a scale
Standard Deviation 2.53
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Pain Right Now Score Week 54 Baseline (n=80, n=97)
|
2.75 units on a scale
Standard Deviation 1.96
|
4.11 units on a scale
Standard Deviation 2.58
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Pain Right Now Score Week 54 Change from Baseline
|
-0.76 units on a scale
Standard Deviation 2.01
|
-1.25 units on a scale
Standard Deviation 2.48
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
General Activity Week 13 Baseline
|
5.07 units on a scale
Standard Deviation 2.26
|
5.60 units on a scale
Standard Deviation 2.29
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
General Activity Week 13 Change from Baseline
|
-1.83 units on a scale
Standard Deviation 2.57
|
-1.51 units on a scale
Standard Deviation 2.86
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
General Activity Week 54 Baseline (n=80, n=97)
|
3.11 units on a scale
Standard Deviation 2.34
|
4.05 units on a scale
Standard Deviation 2.78
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
General Activity Week 54 Change from Baseline
|
-0.86 units on a scale
Standard Deviation 2.10
|
-1.32 units on a scale
Standard Deviation 2.78
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Mood Week 13 Baseline
|
3.89 units on a scale
Standard Deviation 2.56
|
4.30 units on a scale
Standard Deviation 2.76
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Mood Week 13 Change from Baseline
|
-1.70 units on a scale
Standard Deviation 2.73
|
-1.03 units on a scale
Standard Deviation 3.24
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Mood Week 54 Baseline (n=80, n=97)
|
1.89 units on a scale
Standard Deviation 2.33
|
3.24 units on a scale
Standard Deviation 3.00
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Mood Week 54 Change from Baseline
|
-0.44 units on a scale
Standard Deviation 2.19
|
-0.93 units on a scale
Standard Deviation 2.69
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Walking Ability Week 13 Baseline
|
4.49 units on a scale
Standard Deviation 2.66
|
4.83 units on a scale
Standard Deviation 2.76
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Walking Ability Week 13 Change from Baseline
|
-2.01 units on a scale
Standard Deviation 2.91
|
-1.34 units on a scale
Standard Deviation 2.94
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Walking Ability Week 54 Baseline (n=80, n=97)
|
2.49 units on a scale
Standard Deviation 2.61
|
3.53 units on a scale
Standard Deviation 2.83
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Walking Ability Week 54 Change from Baseline
|
-0.51 units on a scale
Standard Deviation 2.14
|
-1.27 units on a scale
Standard Deviation 2.62
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Normal Work Week 13 Baseline
|
5.01 units on a scale
Standard Deviation 2.39
|
5.39 units on a scale
Standard Deviation 2.39
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Normal Work Week 13 Change from Baseline
|
-2.10 units on a scale
Standard Deviation 2.66
|
-1.58 units on a scale
Standard Deviation 3.12
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Normal Work Week 54 Baseline (n=80, n=97)
|
2.85 units on a scale
Standard Deviation 2.49
|
3.81 units on a scale
Standard Deviation 2.72
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Normal Work Week 54 Change from Baseline
|
-0.71 units on a scale
Standard Deviation 2.18
|
-1.09 units on a scale
Standard Deviation 2.32
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Relations With People Week 13 Baseline
|
2.75 units on a scale
Standard Deviation 2.57
|
3.39 units on a scale
Standard Deviation 2.91
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Relations With People Week 13 Change from Baseline
|
-1.28 units on a scale
Standard Deviation 2.76
|
-0.92 units on a scale
Standard Deviation 3.37
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Relations With People Week 54 Baseline (n=80,n=97)
|
1.48 units on a scale
Standard Deviation 1.99
|
2.53 units on a scale
Standard Deviation 2.69
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Relations With People Week 54 Change from Baseline
|
-0.51 units on a scale
Standard Deviation 1.44
|
-0.77 units on a scale
Standard Deviation 2.57
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Sleep Week 13 Baseline
|
4.12 units on a scale
Standard Deviation 2.81
|
4.59 units on a scale
Standard Deviation 2.64
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Sleep Week 13 Change from Baseline
|
-1.66 units on a scale
Standard Deviation 3.19
|
-1.30 units on a scale
Standard Deviation 3.01
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Sleep Week 54 Baseline (n=80, n=97)
|
2.38 units on a scale
Standard Deviation 2.38
|
3.40 units on a scale
Standard Deviation 2.81
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Sleep Week 54 Change from Baseline
|
-1.13 units on a scale
Standard Deviation 2.31
|
-1.08 units on a scale
Standard Deviation 2.38
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Enjoyment of Life Week 13 Baseline
|
3.57 units on a scale
Standard Deviation 2.84
|
3.41 units on a scale
Standard Deviation 2.74
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Enjoyment of Life Week 13 Change from Baseline
|
-1.72 units on a scale
Standard Deviation 2.82
|
-0.81 units on a scale
Standard Deviation 2.96
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Enjoyment of Life Week 54 Baseline (n=80, n=97)
|
1.61 units on a scale
Standard Deviation 2.22
|
2.61 units on a scale
Standard Deviation 2.91
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Enjoyment of Life Week 54 Change from Baseline
|
-0.70 units on a scale
Standard Deviation 2.03
|
-0.93 units on a scale
Standard Deviation 2.33
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Average Interference Week 13 Baseline
|
4.13 units on a scale
Standard Deviation 1.92
|
4.50 units on a scale
Standard Deviation 2.08
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Average Interference Week 13 Change from Baseline
|
-1.76 units on a scale
Standard Deviation 2.04
|
-1.21 units on a scale
Standard Deviation 2.39
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Average Interference Week 54 Baseline (n=80, n=97)
|
2.26 units on a scale
Standard Deviation 1.86
|
3.31 units on a scale
Standard Deviation 2.34
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
Average Interference Week 54 Change from Baseline
|
-0.69 units on a scale
Standard Deviation 1.39
|
-1.06 units on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: Baseline, Week 13, Week 54Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.
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=110 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=117 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)
Week 13 Baseline
|
3.23 units on a scale
Standard Deviation 1.51
|
3.27 units on a scale
Standard Deviation 1.45
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)
Week 13 Change from Baseline
|
-0.94 units on a scale
Standard Deviation 1.29
|
-0.74 units on a scale
Standard Deviation 1.22
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)
Week 54 Baseline (n=81, n=97)
|
2.21 units on a scale
Standard Deviation 1.15
|
2.60 units on a scale
Standard Deviation 1.27
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)
Week 54 Change from Baseline (n=81, n=97)
|
-0.23 units on a scale
Standard Deviation 0.84
|
-0.52 units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Week 13Population: Number of randomized participants with non-missing response values.
Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.
Outcome measures
| Measure |
Duloxetine
n=109 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=115 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria
|
58 participants
|
46 participants
|
SECONDARY outcome
Timeframe: Week 13Population: Number of randomized participants with non-missing response values.
Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.
Outcome measures
| Measure |
Duloxetine
n=109 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=115 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria
|
42 participants
|
31 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 13, Week 54Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.
Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.
Outcome measures
| Measure |
Duloxetine
n=104 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=106 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale
Week 54 Change from Baseline (n=71, n=86)
|
-0.37 units on a scale
Standard Deviation 4.32
|
-1.05 units on a scale
Standard Deviation 4.49
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale
Week 13 Baseline
|
8.03 units on a scale
Standard Deviation 4.63
|
8.29 units on a scale
Standard Deviation 5.26
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale
Week 13 Change from Baseline
|
-2.01 units on a scale
Standard Deviation 4.62
|
-1.50 units on a scale
Standard Deviation 5.05
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale
Week 54 Baseline (n=71, n=86)
|
5.42 units on a scale
Standard Deviation 4.44
|
6.70 units on a scale
Standard Deviation 5.05
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.
Outcome measures
| Measure |
Duloxetine
n=102 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=106 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Mental Component Summary Baseline
|
49.69 units on a scale
Standard Deviation 9.99
|
49.60 units on a scale
Standard Deviation 11.11
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Mental Component Summary Change from Baseline
|
2.05 units on a scale
Standard Deviation 9.90
|
-0.49 units on a scale
Standard Deviation 10.45
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Physical Component Summary Baseline
|
33.39 units on a scale
Standard Deviation 7.61
|
32.62 units on a scale
Standard Deviation 7.37
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Physical Component Summary Change from Baseline
|
5.69 units on a scale
Standard Deviation 9.17
|
4.12 units on a scale
Standard Deviation 8.97
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Bodily Pain Baseline
|
5.48 units on a scale
Standard Deviation 1.38
|
5.42 units on a scale
Standard Deviation 1.39
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Bodily Pain Change from Baseline
|
1.55 units on a scale
Standard Deviation 2.04
|
0.95 units on a scale
Standard Deviation 1.91
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
General Health Baseline
|
16.27 units on a scale
Standard Deviation 4.00
|
15.75 units on a scale
Standard Deviation 4.03
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
General Health Change from Baseline
|
1.73 units on a scale
Standard Deviation 3.57
|
0.82 units on a scale
Standard Deviation 4.08
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Mental Health Baseline
|
22.06 units on a scale
Standard Deviation 4.51
|
21.95 units on a scale
Standard Deviation 4.52
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Mental Health Change from Baseline
|
1.19 units on a scale
Standard Deviation 4.12
|
0.28 units on a scale
Standard Deviation 4.58
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Physical Functioning Baseline
|
19.53 units on a scale
Standard Deviation 4.26
|
19.87 units on a scale
Standard Deviation 4.31
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Physical Functioning Change from Baseline
|
2.59 units on a scale
Standard Deviation 4.51
|
1.61 units on a scale
Standard Deviation 4.26
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Role-Emotional Baseline
|
4.57 units on a scale
Standard Deviation 1.29
|
4.67 units on a scale
Standard Deviation 1.31
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Role-Emotional Change from Baseline
|
0.44 units on a scale
Standard Deviation 1.41
|
0.12 units on a scale
Standard Deviation 1.37
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Role-Physical Baseline
|
5.24 units on a scale
Standard Deviation 1.41
|
5.07 units on a scale
Standard Deviation 1.33
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Role-Physical Change from Baseline
|
0.63 units on a scale
Standard Deviation 1.75
|
0.48 units on a scale
Standard Deviation 1.63
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Social Functioning Baseline
|
7.83 units on a scale
Standard Deviation 1.77
|
7.57 units on a scale
Standard Deviation 1.98
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Social Functioning Change from Baseline
|
0.51 units on a scale
Standard Deviation 1.93
|
0.14 units on a scale
Standard Deviation 2.08
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Vitality Baseline
|
15.16 units on a scale
Standard Deviation 3.33
|
14.79 units on a scale
Standard Deviation 3.69
|
|
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
Vitality Change from Baseline
|
1.08 units on a scale
Standard Deviation 3.93
|
0.21 units on a scale
Standard Deviation 4.31
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.
The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score.
Outcome measures
| Measure |
Duloxetine
n=101 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=102 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)
Baseline
|
0.49 units on a scale
Standard Deviation 0.31
|
0.49 units on a scale
Standard Deviation 0.32
|
|
Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)
Change from Baseline
|
0.16 units on a scale
Standard Deviation 0.32
|
0.11 units on a scale
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Baseline, Week 13, Week 54Population: Number of participants currently being paid to work who had a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment. 1. Absenteeism=(Q2/(Q2+Q4))\*100 2. Presenteeism=(Q5/10)\*100 3. Work productivity loss=(Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))x(Q5/10)\])\*100 4. Activity Impairment=(Q6/10)\*100
Outcome measures
| Measure |
Duloxetine
n=103 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=105 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Work Productivity Loss Week 13 Baseline(n=33,n=29)
|
0.47 units on a scale
Standard Deviation 0.31
|
0.38 units on a scale
Standard Deviation 0.18
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Absenteeism Score Week 13 Baseline (n=35, n=32)
|
0.17 units on a scale
Standard Deviation 0.30
|
0.05 units on a scale
Standard Deviation 0.10
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Absenteeism Score Week 13 Change from Baseline
|
-0.14 units on a scale
Standard Deviation 0.29
|
0.03 units on a scale
Standard Deviation 0.20
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Absenteeism Score Week 54 Baseline (n=24, n=32)
|
0.03 units on a scale
Standard Deviation 0.10
|
0.02 units on a scale
Standard Deviation 0.07
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Absenteeism Score Week 54 Change from Baseline
|
0.01 units on a scale
Standard Deviation 0.12
|
0.01 units on a scale
Standard Deviation 0.14
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Presenteeism Score Week 13 Baseline (n=37, n=31)
|
0.42 units on a scale
Standard Deviation 0.30
|
0.36 units on a scale
Standard Deviation 0.19
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Presenteeism Score Week 13 Change from Baseline
|
-0.17 units on a scale
Standard Deviation 0.32
|
-0.06 units on a scale
Standard Deviation 0.21
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Presenteeism Score Week 54 Baseline (n=24, n=34)
|
0.19 units on a scale
Standard Deviation 0.16
|
0.30 units on a scale
Standard Deviation 0.25
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Presenteeism Score Week 54 Change from Baseline
|
-0.05 units on a scale
Standard Deviation 0.20
|
-0.13 units on a scale
Standard Deviation 0.17
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Work Productivity Loss Week 13 Change
|
-0.19 units on a scale
Standard Deviation 0.30
|
-0.06 units on a scale
Standard Deviation 0.21
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Work Productivity Loss Week 54 Baseline(n=24,n=32)
|
0.21 units on a scale
Standard Deviation 0.19
|
0.32 units on a scale
Standard Deviation 0.26
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Work Productivity Loss Week 54 Change
|
-0.04 units on a scale
Standard Deviation 0.22
|
-0.13 units on a scale
Standard Deviation 0.19
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Activity Impairment Week 13 Baseline (n=103,n=105)
|
0.54 units on a scale
Standard Deviation 0.23
|
0.57 units on a scale
Standard Deviation 0.22
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Activity Impairment Week 13 Change from Baseline
|
-0.20 units on a scale
Standard Deviation 0.29
|
-0.11 units on a scale
Standard Deviation 0.25
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Activity Impairment Week 54 Baseline (n=70, n=86)
|
0.32 units on a scale
Standard Deviation 0.24
|
0.45 units on a scale
Standard Deviation 0.27
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
Activity Impairment Week 54 Change from Baseline
|
-0.06 units on a scale
Standard Deviation 0.20
|
-0.16 units on a scale
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 13, Week 54Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Outcome measures
| Measure |
Duloxetine
n=109 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=116 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores
Week 54 Baseline (n=80, n=97)
|
5.93 units on a scale
Standard Deviation 7.18
|
7.69 units on a scale
Standard Deviation 9.01
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores
Week 13 Baseline
|
6.94 units on a scale
Standard Deviation 7.73
|
6.81 units on a scale
Standard Deviation 6.77
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores
Week 13 Change from Baseline
|
-0.51 units on a scale
Standard Deviation 5.50
|
0.68 units on a scale
Standard Deviation 6.81
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores
Week 54 Change from Baseline (n=80, n=97)
|
-0.64 units on a scale
Standard Deviation 3.98
|
-1.01 units on a scale
Standard Deviation 6.59
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Outcome measures
| Measure |
Duloxetine
n=103 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=105 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores
Anxiety Subscale Baseline (n=102, n=104)
|
4.94 units on a scale
Standard Deviation 3.76
|
4.41 units on a scale
Standard Deviation 3.67
|
|
Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores
Anxiety Subscale Change from Baseline
|
-0.70 units on a scale
Standard Deviation 3.18
|
0.11 units on a scale
Standard Deviation 3.34
|
|
Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores
Depression Subscale Baseline (n=103, n=105)
|
3.65 units on a scale
Standard Deviation 3.22
|
3.87 units on a scale
Standard Deviation 3.42
|
|
Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores
Depression Subscale Change from Baseline
|
-0.27 units on a scale
Standard Deviation 2.58
|
0.10 units on a scale
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of participants with a baseline and at least one non-missing post-baseline value, based on the first values at scheduled visits only. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine
n=102 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=110 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate
Baseline
|
24.90 millimole per Liter (mmol/L)
Standard Deviation 2.80
|
25.10 millimole per Liter (mmol/L)
Standard Deviation 2.94
|
|
Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate
Change from Baseline
|
0.57 millimole per Liter (mmol/L)
Standard Deviation 2.89
|
-0.28 millimole per Liter (mmol/L)
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: Number of participants with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits only. Last observation carried forward.
Outcome measures
| Measure |
Duloxetine
n=104 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=111 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid
Baseline
|
303.23 micromole per Liter (μmol/L)
Standard Deviation 79.04
|
298.07 micromole per Liter (μmol/L)
Standard Deviation 82.63
|
|
Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid
Change from Baseline
|
-6.27 micromole per Liter (μmol/L)
Standard Deviation 37.81
|
8.68 micromole per Liter (μmol/L)
Standard Deviation 43.72
|
SECONDARY outcome
Timeframe: Baseline, Week 13, Week 54Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.
Outcome measures
| Measure |
Duloxetine
n=109 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=115 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate
Week 13 Baseline
|
72.21 beats per minute (bpm)
Standard Deviation 8.90
|
72.31 beats per minute (bpm)
Standard Deviation 9.97
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate
Week 13 Change from Baseline
|
2.05 beats per minute (bpm)
Standard Deviation 10.60
|
-0.90 beats per minute (bpm)
Standard Deviation 10.67
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate
Week 54 Baseline (n=76, n=90)
|
74.95 beats per minute (bpm)
Standard Deviation 10.16
|
71.03 beats per minute (bpm)
Standard Deviation 7.56
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate
Week 54 Change from Baseline
|
-2.46 beats per minute (bpm)
Standard Deviation 10.52
|
1.46 beats per minute (bpm)
Standard Deviation 7.47
|
SECONDARY outcome
Timeframe: Baseline, Week 13, Week 54Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.
Outcome measures
| Measure |
Duloxetine
n=109 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=116 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure
Systolic Blood Pressure (SBP) Week 13 Baseline
|
127.44 mm Hg
Standard Deviation 14.40
|
127.62 mm Hg
Standard Deviation 14.75
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure
SBP Week 13 Change from Baseline
|
-0.94 mm Hg
Standard Deviation 11.12
|
-1.24 mm Hg
Standard Deviation 13.30
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure
SBP Week 54 Baseline (n=76, n=90)
|
127.04 mm Hg
Standard Deviation 14.10
|
127.07 mm Hg
Standard Deviation 14.99
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure
SBP Week 54 Change from Baseline
|
-1.42 mm Hg
Standard Deviation 14.40
|
0.77 mm Hg
Standard Deviation 12.98
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure
Diastolic Blood Pressure (DBP) Week 13 Baseline
|
79.92 mm Hg
Standard Deviation 8.63
|
80.38 mm Hg
Standard Deviation 8.36
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure
DBP Week 13 Change from Baseline
|
0.32 mm Hg
Standard Deviation 8.27
|
-1.25 mm Hg
Standard Deviation 7.47
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure
DBP Week 54 Baseline (n=76, n=90)
|
81.53 mm Hg
Standard Deviation 8.19
|
79.74 mm Hg
Standard Deviation 8.74
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure
DBP Week 54 Change from Baseline
|
-2.00 mm Hg
Standard Deviation 9.37
|
0.50 mm Hg
Standard Deviation 8.02
|
SECONDARY outcome
Timeframe: Baseline, Week 13, Week 54Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.
Outcome measures
| Measure |
Duloxetine
n=109 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=116 Participants
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight
Week 13 Baseline
|
76.63 kilograms (kg)
Standard Deviation 14.83
|
76.29 kilograms (kg)
Standard Deviation 14.01
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight
Week 13 Change from Baseline
|
-0.64 kilograms (kg)
Standard Deviation 2.32
|
0.08 kilograms (kg)
Standard Deviation 1.97
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight
Week 54 Baseline (n=81, n=97)
|
76.57 kilograms (kg)
Standard Deviation 14.61
|
75.34 kilograms (kg)
Standard Deviation 13.42
|
|
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight
Week 54 Change from Baseline
|
1.42 kilograms (kg)
Standard Deviation 3.25
|
-0.38 kilograms (kg)
Standard Deviation 2.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 13 though Week 54Population: Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.
Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.
Outcome measures
| Measure |
Duloxetine
n=181 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Serious Adverse Events During the Dose-Blind Extension Phase
Patients with ≥1 Serious Adverse Event
|
9 participants
|
—
|
|
Serious Adverse Events During the Dose-Blind Extension Phase
Accidental overdose
|
1 participants
|
—
|
|
Serious Adverse Events During the Dose-Blind Extension Phase
Acute tonsillitis
|
1 participants
|
—
|
|
Serious Adverse Events During the Dose-Blind Extension Phase
Angiopathy
|
1 participants
|
—
|
|
Serious Adverse Events During the Dose-Blind Extension Phase
Back pain
|
1 participants
|
—
|
|
Serious Adverse Events During the Dose-Blind Extension Phase
Femur fracture
|
1 participants
|
—
|
|
Serious Adverse Events During the Dose-Blind Extension Phase
Hand fracture
|
1 participants
|
—
|
|
Serious Adverse Events During the Dose-Blind Extension Phase
Osteoarthritis
|
1 participants
|
—
|
|
Serious Adverse Events During the Dose-Blind Extension Phase
Road traffic accident
|
1 participants
|
—
|
|
Serious Adverse Events During the Dose-Blind Extension Phase
Suicidal ideation
|
1 participants
|
—
|
|
Serious Adverse Events During the Dose-Blind Extension Phase
Syncope
|
1 participants
|
—
|
|
Serious Adverse Events During the Dose-Blind Extension Phase
Tonsillitis
|
1 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 13 through Week 54Population: Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.
Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.
Outcome measures
| Measure |
Duloxetine
n=181 Participants
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase
Headache
|
22 participant
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase
Nausea
|
17 participant
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase
Abdominal pain upper
|
13 participant
|
—
|
|
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase
Hyperhidrosis
|
11 participant
|
—
|
Adverse Events
Duloxetine
Serious events: 5 serious events
Other events: 72 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duloxetine
n=115 participants at risk
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=121 participants at risk
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/115 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.83%
1/121 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.87%
1/115 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.00%
0/121 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
2/115 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.00%
0/121 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.87%
1/115 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.00%
0/121 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.87%
1/115 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.00%
0/121 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
Other adverse events
| Measure |
Duloxetine
n=115 participants at risk
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
|
Placebo
n=121 participants at risk
every day (QD), by mouth (PO), 13 weeks
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
2/115 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.00%
0/121 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
3/115 • Number of events 3 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
3.3%
4/121 • Number of events 5 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
2/115 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
1.7%
2/121 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/115 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
2.5%
3/121 • Number of events 3 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
3/115 • Number of events 3 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.83%
1/121 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Nervous system disorders
Dizziness
|
6.1%
7/115 • Number of events 7 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
1.7%
2/121 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Nervous system disorders
Dysgeusia
|
1.7%
2/115 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.83%
1/121 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Nervous system disorders
Headache
|
3.5%
4/115 • Number of events 6 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
9.9%
12/121 • Number of events 14 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Nervous system disorders
Migraine
|
2.6%
3/115 • Number of events 3 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.83%
1/121 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Nervous system disorders
Somnolence
|
5.2%
6/115 • Number of events 6 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.83%
1/121 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Psychiatric disorders
Insomnia
|
4.3%
5/115 • Number of events 5 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
4.1%
5/121 • Number of events 5 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.6%
3/115 • Number of events 3 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.00%
0/121 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.0%
8/115 • Number of events 9 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.83%
1/121 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Cardiac disorders
Tachycardia
|
2.6%
3/115 • Number of events 3 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.00%
0/121 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
3/115 • Number of events 3 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.00%
0/121 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/115 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
1.7%
2/121 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
3/115 • Number of events 3 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.83%
1/121 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
2/115 • Number of events 3 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
1.7%
2/121 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Gastrointestinal disorders
Constipation
|
5.2%
6/115 • Number of events 6 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.83%
1/121 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
8/115 • Number of events 9 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
5.0%
6/121 • Number of events 7 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Gastrointestinal disorders
Dry mouth
|
9.6%
11/115 • Number of events 11 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
3.3%
4/121 • Number of events 4 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
2/115 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.00%
0/121 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Gastrointestinal disorders
Nausea
|
12.2%
14/115 • Number of events 14 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
2.5%
3/121 • Number of events 3 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/115 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.83%
1/121 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
General disorders
Asthenia
|
1.7%
2/115 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.00%
0/121 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
General disorders
Fatigue
|
7.0%
8/115 • Number of events 9 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.83%
1/121 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Infections and infestations
Influenza
|
3.5%
4/115 • Number of events 4 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.83%
1/121 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
3/115 • Number of events 3 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
2.5%
3/121 • Number of events 4 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Infections and infestations
Sinusitis
|
1.7%
2/115 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.00%
0/121 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Infections and infestations
Urinary tract infection
|
0.87%
1/115 • Number of events 1 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
1.7%
2/121 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
|
Investigations
Weight increased
|
1.7%
2/115 • Number of events 2 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
0.00%
0/121 • Adverse event data in this module is for the 13 Week acute double-blind treatment phase.
|
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