Trial Outcomes & Findings for A Study for Patient With Chronic Low Back Pain (NCT NCT00767806)
NCT ID: NCT00767806
Last Updated: 2010-10-18
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). Least Squares Mean values were controlled for investigator and baseline severity.
COMPLETED
PHASE3
401 participants
baseline, 12 weeks
2010-10-18
Participant Flow
Participant milestones
| Measure |
Duloxetine
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
203
|
|
Overall Study
COMPLETED
|
147
|
156
|
|
Overall Study
NOT COMPLETED
|
51
|
47
|
Reasons for withdrawal
| Measure |
Duloxetine
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Overall Study
Adverse Event
|
30
|
11
|
|
Overall Study
Withdrawal by Subject
|
8
|
13
|
|
Overall Study
Protocol Violation
|
6
|
5
|
|
Overall Study
Lack of Efficacy
|
1
|
9
|
|
Overall Study
Physician Decision
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Entry Criteria Not Met
|
1
|
1
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
Baseline Characteristics
A Study for Patient With Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Duloxetine
n=198 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=203 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
54.87 years
STANDARD_DEVIATION 13.27 • n=5 Participants
|
53.43 years
STANDARD_DEVIATION 14.17 • n=7 Participants
|
54.14 years
STANDARD_DEVIATION 13.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
189 participants
n=5 Participants
|
193 participants
n=7 Participants
|
382 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 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
United States
|
64 participants
n=5 Participants
|
67 participants
n=7 Participants
|
131 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
35 participants
n=5 Participants
|
33 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
23 participants
n=5 Participants
|
26 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Quebec Task Force on Spinal Disorders
Class 1
|
173 participants
n=5 Participants
|
168 participants
n=7 Participants
|
341 participants
n=5 Participants
|
|
Quebec Task Force on Spinal Disorders
Class 2
|
21 participants
n=5 Participants
|
30 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Quebec Task Force on Spinal Disorders
Not Available
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.56 kilogram/meter squared
STANDARD_DEVIATION 4.50 • n=5 Participants
|
28.14 kilogram/meter squared
STANDARD_DEVIATION 4.72 • n=7 Participants
|
27.85 kilogram/meter squared
STANDARD_DEVIATION 4.62 • n=5 Participants
|
|
Brief Pain Inventory Average Pain Rating
|
5.84 units on a scale
STANDARD_DEVIATION 1.43 • n=5 Participants
|
5.75 units on a scale
STANDARD_DEVIATION 1.37 • n=7 Participants
|
5.79 units on a scale
STANDARD_DEVIATION 1.40 • n=5 Participants
|
|
Clinical Global Impression - Severity (CGI-S)
|
3.49 units on a scale
STANDARD_DEVIATION 1.24 • n=5 Participants
|
3.29 units on a scale
STANDARD_DEVIATION 1.28 • n=7 Participants
|
3.39 units on a scale
STANDARD_DEVIATION 1.27 • n=5 Participants
|
|
Duration of Chronic Lower Back Pain
|
8.28 years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
8.74 years
STANDARD_DEVIATION 8.95 • n=7 Participants
|
8.51 years
STANDARD_DEVIATION 8.57 • n=5 Participants
|
|
Height
|
168.24 centimeter
STANDARD_DEVIATION 9.64 • n=5 Participants
|
167.91 centimeter
STANDARD_DEVIATION 8.82 • n=7 Participants
|
168.07 centimeter
STANDARD_DEVIATION 9.22 • n=5 Participants
|
|
Roland Morris Disability Questionnaire
|
9.63 units on a scale
STANDARD_DEVIATION 4.64 • n=5 Participants
|
9.32 units on a scale
STANDARD_DEVIATION 4.77 • n=7 Participants
|
9.47 units on a scale
STANDARD_DEVIATION 4.70 • n=5 Participants
|
|
Weekly mean of 24-hour average pain rating using an 11-point numerical scale patient diary
|
5.79 units on a scale
STANDARD_DEVIATION 1.36 • n=5 Participants
|
5.80 units on a scale
STANDARD_DEVIATION 1.37 • n=7 Participants
|
5.80 units on a scale
STANDARD_DEVIATION 1.36 • n=5 Participants
|
|
Weight
|
78.30 kilogram
STANDARD_DEVIATION 15.83 • n=5 Participants
|
79.35 kilogram
STANDARD_DEVIATION 14.65 • n=7 Participants
|
78.83 kilogram
STANDARD_DEVIATION 15.23 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 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). Least Squares Mean values were controlled for investigator and baseline severity.
Outcome measures
| Measure |
Duloxetine
n=195 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=199 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score
|
-2.48 units on a scale
Standard Error 0.16
|
-1.80 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
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 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=195 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=199 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI severity of worst pain - baseline
|
7.26 units on a scale
Standard Deviation 1.52
|
7.06 units on a scale
Standard Deviation 1.54
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI severity of worst pain - change
|
-2.75 units on a scale
Standard Deviation 2.33
|
-1.99 units on a scale
Standard Deviation 2.29
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI severity of least pain - baseline
|
4.11 units on a scale
Standard Deviation 2.07
|
4.04 units on a scale
Standard Deviation 2.03
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI severity of least pain - change
|
-1.67 units on a scale
Standard Deviation 2.01
|
-1.16 units on a scale
Standard Deviation 2.04
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI severity of pain right now - baseline
|
5.47 units on a scale
Standard Deviation 2.00
|
5.30 units on a scale
Standard Deviation 1.84
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI severity of pain right now - change
|
-2.55 units on a scale
Standard Deviation 2.27
|
-1.65 units on a scale
Standard Deviation 2.05
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference with general activity - baseline
|
5.37 units on a scale
Standard Deviation 2.33
|
4.91 units on a scale
Standard Deviation 2.16
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference with general activity - change
|
-2.71 units on a scale
Standard Deviation 2.39
|
-1.71 units on a scale
Standard Deviation 2.30
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference with mood - baseline
|
4.00 units on a scale
Standard Deviation 2.70
|
3.76 units on a scale
Standard Deviation 2.54
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference with mood - change
|
-2.26 units on a scale
Standard Deviation 2.45
|
-1.41 units on a scale
Standard Deviation 2.40
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference with walking ability - baseline
|
4.61 units on a scale
Standard Deviation 2.66
|
4.13 units on a scale
Standard Deviation 2.57
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference with walking ability - change
|
-2.23 units on a scale
Standard Deviation 2.42
|
-1.52 units on a scale
Standard Deviation 2.27
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference with normal work - baseline
|
5.25 units on a scale
Standard Deviation 2.33
|
4.91 units on a scale
Standard Deviation 2.33
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference with normal work - change
|
-2.50 units on a scale
Standard Deviation 2.44
|
-1.82 units on a scale
Standard Deviation 2.22
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference relations with others - baseline
|
3.07 units on a scale
Standard Deviation 2.67
|
2.82 units on a scale
Standard Deviation 2.58
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference relations with others - change
|
-1.74 units on a scale
Standard Deviation 2.35
|
-1.04 units on a scale
Standard Deviation 2.37
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference with sleep - baseline
|
4.74 units on a scale
Standard Deviation 2.89
|
4.53 units on a scale
Standard Deviation 2.79
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference with sleep - change
|
-2.37 units on a scale
Standard Deviation 2.67
|
-1.55 units on a scale
Standard Deviation 2.55
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference with enjoyment of life - baseline
|
4.25 units on a scale
Standard Deviation 2.84
|
3.78 units on a scale
Standard Deviation 2.70
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI interference with enjoyment of life - change
|
-2.44 units on a scale
Standard Deviation 2.56
|
-1.59 units on a scale
Standard Deviation 2.55
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI average interference - baseline
|
4.44 units on a scale
Standard Deviation 2.15
|
4.14 units on a scale
Standard Deviation 2.08
|
|
Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
BPI average interference - change
|
-2.26 units on a scale
Standard Deviation 1.96
|
-1.55 units on a scale
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients completed the electronic diary at bedtime. The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Least Squares Mean values were controlled for investigator and baseline severity.
Outcome measures
| Measure |
Duloxetine
n=152 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=162 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating
Average Pain
|
-2.14 units on a scale
Standard Error 0.14
|
-1.43 units on a scale
Standard Error 0.13
|
|
Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating
Worst Pain
|
-2.19 units on a scale
Standard Error 0.15
|
-1.48 units on a scale
Standard Error 0.14
|
|
Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating
Night Pain
|
-1.62 units on a scale
Standard Error 0.14
|
-1.10 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.
Outcome measures
| Measure |
Duloxetine
n=195 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=199 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint
|
111 participants
|
97 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.
Outcome measures
| Measure |
Duloxetine
n=195 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=199 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint
|
95 participants
|
69 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit. BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of sustained responders was assessed at endpoint.
Outcome measures
| Measure |
Duloxetine
n=195 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=199 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Number of Sustained Responders at 12 Week Endpoint
|
89 participants
|
73 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All randomized participants with non-missing baseline value; baseline observation carried forward method was used to impute missing endpoints.
The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: 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). Number of participants under each threshold was assessed at endpoint.
Outcome measures
| Measure |
Duloxetine
n=203 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=198 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
Any Increase
|
12 participants
|
15 participants
|
|
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
No Change
|
62 participants
|
67 participants
|
|
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
>0% Decrease
|
124 participants
|
121 participants
|
|
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
>=10% Decrease
|
124 participants
|
121 participants
|
|
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
>=20% Decrease
|
116 participants
|
106 participants
|
|
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
>=30% Decrease
|
95 participants
|
83 participants
|
|
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
>=40% Decrease
|
90 participants
|
71 participants
|
|
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
>=50% Decrease
|
85 participants
|
57 participants
|
|
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
>=60% Decrease
|
61 participants
|
38 participants
|
|
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
>=70% Decrease
|
47 participants
|
30 participants
|
|
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
>=80% Decrease
|
32 participants
|
19 participants
|
|
Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
100% Decrease
|
15 participants
|
11 participants
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
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 patients). Least Squares Mean values were controlled for investigator and baseline severity.
Outcome measures
| Measure |
Duloxetine
n=195 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=199 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)
|
-0.95 units on a scale
Standard Error 0.07
|
-0.79 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Least Squares Mean values were controlled for investigator and baseline severity.
Outcome measures
| Measure |
Duloxetine
n=194 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=199 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Patient's Global Impression of Improvement (PGI-I) at 12 Weeks
|
2.88 units on a scale
Standard Error 0.09
|
3.19 units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
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). Least Squares Mean values were controlled for investigator and baseline severity.
Outcome measures
| Measure |
Duloxetine
n=178 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=179 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire
|
-2.69 units on a scale
Standard Error 0.31
|
-2.22 units on a scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed).
Outcome measures
| Measure |
Duloxetine
n=186 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=188 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Tension-Anxiety - baseline; n=186,n=185
|
4.22 units on a scale
Standard Deviation 3.78
|
4.29 units on a scale
Standard Deviation 3.70
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Tension-Anxiety - change; n=186,n=185
|
-1.58 units on a scale
Standard Deviation 3.48
|
-0.78 units on a scale
Standard Deviation 3.17
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Depression-Dejection - baseline; n=185,n=188
|
2.67 units on a scale
Standard Deviation 3.63
|
2.74 units on a scale
Standard Deviation 3.44
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Depression-Dejection - change; n=185,n=188
|
-0.80 units on a scale
Standard Deviation 3.28
|
-0.45 units on a scale
Standard Deviation 3.07
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Anger-Hostility - baseline; n=186,n=185
|
2.79 units on a scale
Standard Deviation 3.60
|
3.46 units on a scale
Standard Deviation 4.11
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Anger-Hostility - change; n=186,n=185
|
-1.18 units on a scale
Standard Deviation 3.07
|
-0.63 units on a scale
Standard Deviation 3.38
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Vigor-Activity - baseline; n=185, n=187
|
6.77 units on a scale
Standard Deviation 4.30
|
7.23 units on a scale
Standard Deviation 3.87
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Vigor-Activity - change; n=185, n=187
|
2.13 units on a scale
Standard Deviation 4.53
|
0.81 units on a scale
Standard Deviation 3.88
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Fatigue-Inertia - baseline; n=184, n=188
|
6.49 units on a scale
Standard Deviation 4.33
|
6.71 units on a scale
Standard Deviation 4.67
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Fatigue-Inertia - change; n=184, n=188
|
-1.74 units on a scale
Standard Deviation 3.96
|
-1.64 units on a scale
Standard Deviation 4.31
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Confusion-Bewilderment - baseline; n=185, n=187
|
4.09 units on a scale
Standard Deviation 2.89
|
4.07 units on a scale
Standard Deviation 2.79
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Confusion-Bewilderment - change; n=185, n=187
|
-0.69 units on a scale
Standard Deviation 2.71
|
-0.14 units on a scale
Standard Deviation 2.47
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Total Mood Disturbance - baseline; n=181, n=180
|
13.31 units on a scale
Standard Deviation 16.67
|
14.27 units on a scale
Standard Deviation 17.39
|
|
Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Total Mood Disturbance - change; n=181, n=180
|
-7.90 units on a scale
Standard Deviation 14.06
|
-4.68 units on a scale
Standard Deviation 14.54
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
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 \[PCS\]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning).
Outcome measures
| Measure |
Duloxetine
n=190 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=188 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Physical Component - baseline; n=147, n=153
|
34.41 units on a scale
Standard Deviation 8.18
|
34.29 units on a scale
Standard Deviation 7.75
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Physical Component - change; n=147, n=153
|
6.15 units on a scale
Standard Deviation 8.85
|
5.22 units on a scale
Standard Deviation 8.25
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Mental Component - baseline; n=147, n=153
|
49.50 units on a scale
Standard Deviation 12.33
|
49.59 units on a scale
Standard Deviation 10.35
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Mental Component - change; n=147, n=153
|
3.34 units on a scale
Standard Deviation 9.26
|
0.84 units on a scale
Standard Deviation 8.58
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Bodily Pain - baseline; n=188, n=190
|
33.37 units on a scale
Standard Deviation 13.94
|
33.93 units on a scale
Standard Deviation 13.81
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Bodily Pain -change; n=188, n=190
|
18.31 units on a scale
Standard Deviation 19.25
|
13.52 units on a scale
Standard Deviation 20.15
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Mental Health - baseline; n=165, n=166
|
69.30 units on a scale
Standard Deviation 19.19
|
69.72 units on a scale
Standard Deviation 16.73
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Mental Health - change; n=165, n=166
|
6.65 units on a scale
Standard Deviation 15.98
|
1.48 units on a scale
Standard Deviation 14.21
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
General Health - baseline; n=188, n=190
|
53.54 units on a scale
Standard Deviation 19.31
|
53.11 units on a scale
Standard Deviation 22.12
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
General Health - change; n=188, n=190
|
7.81 units on a scale
Standard Deviation 17.94
|
5.34 units on a scale
Standard Deviation 18.06
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Physical Functioning - baseline;n=186, n=189
|
50.02 units on a scale
Standard Deviation 22.63
|
52.13 units on a scale
Standard Deviation 21.17
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Physical Functioning - change; n=186, n=189
|
13.18 units on a scale
Standard Deviation 20.48
|
9.42 units on a scale
Standard Deviation 17.63
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Role-Emotional - baseline; n=172, n=179
|
73.89 units on a scale
Standard Deviation 26.63
|
74.21 units on a scale
Standard Deviation 25.64
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Role-Emotional - change; n=172, n=179
|
8.19 units on a scale
Standard Deviation 21.90
|
5.12 units on a scale
Standard Deviation 23.52
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Role-Physical - baseline; n=172, n=179
|
46.77 units on a scale
Standard Deviation 22.37
|
46.42 units on a scale
Standard Deviation 23.68
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Role-Physical - change; n=172, n=179
|
12.97 units on a scale
Standard Deviation 22.24
|
11.66 units on a scale
Standard Deviation 22.89
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Social Functioning -baseline; n=188, n=190
|
67.02 units on a scale
Standard Deviation 24.28
|
69.67 units on a scale
Standard Deviation 24.03
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Social Functioning - change; n=188, n=190
|
12.70 units on a scale
Standard Deviation 22.18
|
7.11 units on a scale
Standard Deviation 21.02
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Vitality - baseline; n=163, n=165
|
50.69 units on a scale
Standard Deviation 19.08
|
48.64 units on a scale
Standard Deviation 18.92
|
|
Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Vitality - change; n=163, n=165
|
9.33 units on a scale
Standard Deviation 18.94
|
6.30 units on a scale
Standard Deviation 18.40
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
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 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score.
Outcome measures
| Measure |
Duloxetine
n=190 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=192 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension
UK population-based Index Score-baseline
|
0.52 units on a scale
Standard Deviation 0.27
|
0.57 units on a scale
Standard Deviation 0.24
|
|
Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension
UK population-based Index Score-change
|
0.19 units on a scale
Standard Deviation 0.31
|
0.07 units on a scale
Standard Deviation 0.26
|
|
Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension
US population-based Index Score-baseline
|
0.66 units on a scale
Standard Deviation 0.17
|
0.69 units on a scale
Standard Deviation 0.16
|
|
Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension
US population-based Index Score-change
|
0.12 units on a scale
Standard Deviation 0.21
|
0.05 units on a scale
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints. Not for all participants were data for all WPAI items available.
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. 1. Absenteeism 2. Presenteeism 3. Work productivity loss 4. Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment.
Outcome measures
| Measure |
Duloxetine
n=190 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=196 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)
Absenteeism, baseline; n=79, n=93
|
0.08 units on a scale
Standard Deviation 0.20
|
0.10 units on a scale
Standard Deviation 0.25
|
|
Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)
Absenteeism, change; n=79, n=93
|
-0.03 units on a scale
Standard Deviation 0.18
|
-0.03 units on a scale
Standard Deviation 0.18
|
|
Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)
Presenteeism, baseline; n=79, n=90
|
0.49 units on a scale
Standard Deviation 0.25
|
0.48 units on a scale
Standard Deviation 0.22
|
|
Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)
Presenteeism, change; n=79, n=90
|
-0.22 units on a scale
Standard Deviation 0.24
|
-0.18 units on a scale
Standard Deviation 0.23
|
|
Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)
Work Productivity Loss, baseline; n=77, n=89
|
0.50 units on a scale
Standard Deviation 0.25
|
0.50 units on a scale
Standard Deviation 0.23
|
|
Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)
Work Productivity Loss, change; n=77, n=89
|
-0.22 units on a scale
Standard Deviation 0.26
|
-0.18 units on a scale
Standard Deviation 0.25
|
|
Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)
Activity Impairment, baseline; n=190, n=196
|
0.56 units on a scale
Standard Deviation 0.22
|
0.56 units on a scale
Standard Deviation 0.19
|
|
Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)
Activity Impairment, change; n=190, n=196
|
-0.23 units on a scale
Standard Deviation 0.25
|
-0.17 units on a scale
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants.
Reasons for discontinuation are listed in the participant flow.
Outcome measures
| Measure |
Duloxetine
n=198 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=203 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Participants Who Discontinued From Baseline to 12 Weeks
|
51 participants
|
47 participants
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
Least Squares Mean values were controlled for investigator.
Outcome measures
| Measure |
Duloxetine
n=190 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=194 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Weeks in Uric Acid
|
-14.06 Micromole/Liter
Standard Error 4.60
|
1.34 Micromole/Liter
Standard Error 4.64
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
Least Squares Mean values were controlled for investigator.
Outcome measures
| Measure |
Duloxetine
n=190 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=194 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Albumin
|
-0.76 Gram/Liter
Standard Deviation 0.23
|
-0.12 Gram/Liter
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
Least Squares Mean values were controlled for investigator.
Outcome measures
| Measure |
Duloxetine
n=190 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=194 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase
|
1.59 Units/Liter
Standard Error 0.94
|
-1.85 Units/Liter
Standard Error 0.94
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing. endpoints.
Least Squares Mean values were controlled for investigator.
Outcome measures
| Measure |
Duloxetine
n=190 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=194 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase
|
1.51 Units/Liter
Standard Error 1.01
|
-1.71 Units/Liter
Standard Error 1.01
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
Least Squares Mean values were controlled for investigator.
Outcome measures
| Measure |
Duloxetine
n=190 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=194 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase
|
1.90 Units/Liter
Standard Error 0.92
|
-0.54 Units/Liter
Standard Error 0.92
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
Least Squares Mean values were controlled for investigator.
Outcome measures
| Measure |
Duloxetine
n=190 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=194 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Creatinine
|
-1.69 Micromole/Liter
Standard Error 0.82
|
0.70 Micromole/Liter
Standard Error 0.82
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
Least Squares Mean values were controlled for investigator.
Outcome measures
| Measure |
Duloxetine
n=190 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=194 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Total Protein
|
-1.34 Gram/Liter
Standard Error 0.30
|
-0.43 Gram/Liter
Standard Error 0.30
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
Least Squares Mean values were controlled for investigator.
Outcome measures
| Measure |
Duloxetine
n=194 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=198 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Weeks in Blood Pressure
Systolic Blood Pressure (millimeter mercury)
|
0.49 millimeter mercury
Standard Error 0.85
|
-0.59 millimeter mercury
Standard Error 0.85
|
|
Change From Baseline to 12 Weeks in Blood Pressure
Diastolic Blood Pressure (millimeter mercury)
|
-0.14 millimeter mercury
Standard Error 0.67
|
-0.64 millimeter mercury
Standard Error 0.67
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
Least Squares Mean values were controlled for investigator.
Outcome measures
| Measure |
Duloxetine
n=194 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=198 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Weight
|
-0.31 kilogram
Standard Error 0.17
|
0.05 kilogram
Standard Error 0.17
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.
Least Squares Mean values were controlled for investigator.
Outcome measures
| Measure |
Duloxetine
n=194 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=198 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Pulse Rate
|
0.18 beats per minute
Standard Error 0.65
|
-0.17 beats per minute
Standard Error 0.64
|
SECONDARY outcome
Timeframe: baseline through 12 weeksPopulation: All randomized participants.
The Columbia Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred.
Outcome measures
| Measure |
Duloxetine
n=198 Participants
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=203 Participants
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale
|
0 participants
|
0 participants
|
Adverse Events
Duloxetine
Placebo
Serious adverse events
| Measure |
Duloxetine
n=198 participants at risk
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=203 participants at risk
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Ear and labyrinth disorders
Vertigo
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Musculoskeletal and connective tissue disorders
Myopathy toxic
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
Other adverse events
| Measure |
Duloxetine
n=198 participants at risk
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
|
Placebo
n=203 participants at risk
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/198
|
1.5%
3/203 • Number of events 3
|
|
Ear and labyrinth disorders
Tinnitus
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Ear and labyrinth disorders
Vertigo
|
2.5%
5/198 • Number of events 5
|
1.5%
3/203 • Number of events 3
|
|
Eye disorders
Vision blurred
|
1.0%
2/198 • Number of events 2
|
0.49%
1/203 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
2/198 • Number of events 2
|
2.0%
4/203 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
6.1%
12/198 • Number of events 12
|
3.4%
7/203 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
9/198 • Number of events 9
|
3.0%
6/203 • Number of events 6
|
|
Gastrointestinal disorders
Dry mouth
|
6.6%
13/198 • Number of events 14
|
2.0%
4/203 • Number of events 4
|
|
Gastrointestinal disorders
Flatulence
|
1.5%
3/198 • Number of events 3
|
0.99%
2/203 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
17.7%
35/198 • Number of events 35
|
3.0%
6/203 • Number of events 7
|
|
Gastrointestinal disorders
Toothache
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
3/198 • Number of events 3
|
1.5%
3/203 • Number of events 3
|
|
General disorders
Asthenia
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
General disorders
Fatigue
|
3.5%
7/198 • Number of events 7
|
1.5%
3/203 • Number of events 3
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Infections and infestations
Bronchitis
|
0.00%
0/198
|
2.0%
4/203 • Number of events 4
|
|
Infections and infestations
Influenza
|
1.5%
3/198 • Number of events 4
|
2.5%
5/203 • Number of events 5
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
5/198 • Number of events 5
|
2.0%
4/203 • Number of events 4
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/198
|
1.5%
3/203 • Number of events 3
|
|
Infections and infestations
Rhinitis
|
1.0%
2/198 • Number of events 2
|
0.99%
2/203 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
0.51%
1/198 • Number of events 1
|
1.5%
3/203 • Number of events 3
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
4/198 • Number of events 5
|
3.9%
8/203 • Number of events 9
|
|
Infections and infestations
Viral infection
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/198
|
1.5%
3/203 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
2.0%
4/198 • Number of events 4
|
0.00%
0/203
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/198
|
1.5%
3/203 • Number of events 3
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.51%
1/198 • Number of events 1
|
3.4%
7/203 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
3/198 • Number of events 3
|
1.5%
3/203 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.0%
2/198 • Number of events 2
|
2.0%
4/203 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.0%
2/198 • Number of events 4
|
0.49%
1/203 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
5.1%
10/198 • Number of events 10
|
1.5%
3/203 • Number of events 3
|
|
Nervous system disorders
Headache
|
13.6%
27/198 • Number of events 54
|
12.3%
25/203 • Number of events 35
|
|
Nervous system disorders
Migraine
|
1.0%
2/198 • Number of events 2
|
0.49%
1/203 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.51%
1/198 • Number of events 1
|
1.5%
3/203 • Number of events 3
|
|
Nervous system disorders
Somnolence
|
5.1%
10/198 • Number of events 10
|
0.99%
2/203 • Number of events 2
|
|
Nervous system disorders
Tension headache
|
0.00%
0/198
|
1.5%
3/203 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
1.0%
2/198 • Number of events 2
|
0.99%
2/203 • Number of events 2
|
|
Psychiatric disorders
Confusional state
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Psychiatric disorders
Insomnia
|
2.5%
5/198 • Number of events 5
|
3.0%
6/203 • Number of events 6
|
|
Psychiatric disorders
Libido decreased
|
2.0%
4/198 • Number of events 4
|
0.49%
1/203 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Renal and urinary disorders
Urine flow decreased
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
2.0%
4/198 • Number of events 4
|
0.00%
0/203
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.5%
5/198 • Number of events 5
|
0.99%
2/203 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
2/198 • Number of events 3
|
0.49%
1/203 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.0%
2/198 • Number of events 2
|
0.99%
2/203 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60