Trial Outcomes & Findings for A Study for the Treatment of Diabetic Peripheral Neuropathic Pain (NCT NCT00552175)
NCT ID: NCT00552175
Last Updated: 2010-04-13
Results Overview
Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument 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
339 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2010-04-13
Participant Flow
Full Analysis Set Population consisted of all randomized patients who had at least one post-baseline measure of the primary efficacy variable.
Participant milestones
| Measure |
Placebo
placebo comparator taken orally every day
|
Duloxetine 40 mg
Duloxetine 40 milligrams (mg) taken orally every day
|
Duloxetine 60 mg
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Overall Study
STARTED
|
167
|
86
|
86
|
|
Overall Study
Full Analysis Set Population
|
167
|
85
|
86
|
|
Overall Study
COMPLETED
|
150
|
73
|
72
|
|
Overall Study
NOT COMPLETED
|
17
|
13
|
14
|
Reasons for withdrawal
| Measure |
Placebo
placebo comparator taken orally every day
|
Duloxetine 40 mg
Duloxetine 40 milligrams (mg) taken orally every day
|
Duloxetine 60 mg
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
1
|
|
Overall Study
Adverse Event
|
9
|
9
|
10
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Entry Criteria Not Met
|
1
|
1
|
0
|
|
Overall Study
Reason Not Specified
|
3
|
1
|
1
|
Baseline Characteristics
A Study for the Treatment of Diabetic Peripheral Neuropathic Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=167 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg
n=85 Participants
Duloxetine 40 milligrams (mg) taken orally every day
|
Duloxetine 60 mg
n=86 Participants
Duloxetine 60 milligrams (mg) taken orally every day
|
Total
n=338 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
60.8 years
STANDARD_DEVIATION 9.2 • n=93 Participants
|
62.1 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
59.7 years
STANDARD_DEVIATION 12.1 • n=27 Participants
|
60.8 years
STANDARD_DEVIATION 10 • n=483 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
82 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
256 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
167 participants
n=93 Participants
|
85 participants
n=4 Participants
|
86 participants
n=27 Participants
|
338 participants
n=483 Participants
|
|
Region of Enrollment
Japan
|
167 participants
n=93 Participants
|
85 participants
n=4 Participants
|
86 participants
n=27 Participants
|
338 participants
n=483 Participants
|
|
Duration of Diabetes
<5 years
|
33 participants
n=93 Participants
|
20 participants
n=4 Participants
|
16 participants
n=27 Participants
|
69 participants
n=483 Participants
|
|
Duration of Diabetes
5 - 10 years
|
32 participants
n=93 Participants
|
18 participants
n=4 Participants
|
14 participants
n=27 Participants
|
64 participants
n=483 Participants
|
|
Duration of Diabetes
>= 10 years
|
97 participants
n=93 Participants
|
47 participants
n=4 Participants
|
56 participants
n=27 Participants
|
200 participants
n=483 Participants
|
|
Duration of Diabetes
Unknown
|
5 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
5 participants
n=483 Participants
|
|
Type of Diabetes
Type I
|
8 participants
n=93 Participants
|
5 participants
n=4 Participants
|
4 participants
n=27 Participants
|
17 participants
n=483 Participants
|
|
Type of Diabetes
Type II
|
159 participants
n=93 Participants
|
80 participants
n=4 Participants
|
82 participants
n=27 Participants
|
321 participants
n=483 Participants
|
|
Beck Depression Inventory-II (BDI-II)
|
8.8 units on a scale
STANDARD_DEVIATION 6.8 • n=93 Participants
|
9.4 units on a scale
STANDARD_DEVIATION 8.8 • n=4 Participants
|
9.4 units on a scale
STANDARD_DEVIATION 7.2 • n=27 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 7.4 • n=483 Participants
|
|
Body Mass Index (BMI)
|
23.90 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 3.70 • n=93 Participants
|
23.27 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 3.67 • n=4 Participants
|
24.20 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 3.50 • n=27 Participants
|
23.82 kilograms/square meters (kg/m^2)
STANDARD_DEVIATION 3.65 • n=483 Participants
|
|
Brief Pain Inventory (BPI) Interference Scores
General Activity
|
4.4 units on a scale
STANDARD_DEVIATION 2.4 • n=93 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 2.7 • n=4 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 2.4 • n=27 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 2.5 • n=483 Participants
|
|
Brief Pain Inventory (BPI) Interference Scores
Mood
|
4.2 units on a scale
STANDARD_DEVIATION 2.4 • n=93 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 2.5 • n=4 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 2.5 • n=27 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 2.5 • n=483 Participants
|
|
Brief Pain Inventory (BPI) Interference Scores
Walking Ability
|
4.0 units on a scale
STANDARD_DEVIATION 2.6 • n=93 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 2.8 • n=4 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 2.5 • n=27 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 2.6 • n=483 Participants
|
|
Brief Pain Inventory (BPI) Interference Scores
Normal Work
|
3.7 units on a scale
STANDARD_DEVIATION 2.7 • n=93 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 2.6 • n=4 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 2.5 • n=27 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 2.6 • n=483 Participants
|
|
Brief Pain Inventory (BPI) Interference Scores
Relation to People
|
2.6 units on a scale
STANDARD_DEVIATION 2.5 • n=93 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 2.7 • n=4 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 2.4 • n=27 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 2.5 • n=483 Participants
|
|
Brief Pain Inventory (BPI) Interference Scores
Sleep
|
3.9 units on a scale
STANDARD_DEVIATION 2.7 • n=93 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 2.8 • n=4 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 2.7 • n=27 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 2.7 • n=483 Participants
|
|
Brief Pain Inventory (BPI) Interference Scores
Enjoyment of Life
|
3.5 units on a scale
STANDARD_DEVIATION 2.5 • n=93 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 2.7 • n=4 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 2.5 • n=27 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 2.6 • n=483 Participants
|
|
Brief Pain Inventory (BPI) Interference Scores
Average of Interference Scores
|
3.75 units on a scale
STANDARD_DEVIATION 2.15 • n=93 Participants
|
3.88 units on a scale
STANDARD_DEVIATION 2.25 • n=4 Participants
|
4.09 units on a scale
STANDARD_DEVIATION 2.13 • n=27 Participants
|
3.87 units on a scale
STANDARD_DEVIATION 2.17 • n=483 Participants
|
|
Brief Pain Inventory (BPI) Severity Scores
Worst Pain
|
6.7 units on a scale
STANDARD_DEVIATION 1.4 • n=93 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 1.4 • n=4 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 1.5 • n=27 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 1.4 • n=483 Participants
|
|
Brief Pain Inventory (BPI) Severity Scores
Least Pain
|
4.1 units on a scale
STANDARD_DEVIATION 1.8 • n=93 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 1.8 • n=4 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 1.6 • n=27 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 1.8 • n=483 Participants
|
|
Brief Pain Inventory (BPI) Severity Scores
Average Pain
|
5.6 units on a scale
STANDARD_DEVIATION 1.3 • n=93 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.3 • n=4 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 1.3 • n=27 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.3 • n=483 Participants
|
|
Brief Pain Inventory (BPI) Severity Scores
Pain Right Now
|
5.1 units on a scale
STANDARD_DEVIATION 1.7 • n=93 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 1.8 • n=4 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 1.4 • n=27 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 1.7 • n=483 Participants
|
|
Duration of Diabetic Neuropathy
|
4.21 years
STANDARD_DEVIATION 4.44 • n=93 Participants
|
4.58 years
STANDARD_DEVIATION 3.90 • n=4 Participants
|
4.16 years
STANDARD_DEVIATION 3.67 • n=27 Participants
|
4.29 years
STANDARD_DEVIATION 4.11 • n=483 Participants
|
|
Height
|
164.13 centimeters (cm)
STANDARD_DEVIATION 8.65 • n=93 Participants
|
163.63 centimeters (cm)
STANDARD_DEVIATION 8.78 • n=4 Participants
|
164.02 centimeters (cm)
STANDARD_DEVIATION 7.32 • n=27 Participants
|
163.98 centimeters (cm)
STANDARD_DEVIATION 8.34 • n=483 Participants
|
|
Weekly Means of 24-Hour Average Pain, Worst Pain, and Night Pain Diary Scores
Average Pain Score
|
5.78 units on a scale
STANDARD_DEVIATION 1.17 • n=93 Participants
|
5.79 units on a scale
STANDARD_DEVIATION 1.23 • n=4 Participants
|
5.76 units on a scale
STANDARD_DEVIATION 1.17 • n=27 Participants
|
5.78 units on a scale
STANDARD_DEVIATION 1.18 • n=483 Participants
|
|
Weekly Means of 24-Hour Average Pain, Worst Pain, and Night Pain Diary Scores
Worst Pain Score
|
6.66 units on a scale
STANDARD_DEVIATION 1.25 • n=93 Participants
|
6.54 units on a scale
STANDARD_DEVIATION 1.33 • n=4 Participants
|
6.61 units on a scale
STANDARD_DEVIATION 1.33 • n=27 Participants
|
6.62 units on a scale
STANDARD_DEVIATION 1.29 • n=483 Participants
|
|
Weekly Means of 24-Hour Average Pain, Worst Pain, and Night Pain Diary Scores
Night Pain Score
|
5.5 units on a scale
STANDARD_DEVIATION 1.49 • n=93 Participants
|
5.55 units on a scale
STANDARD_DEVIATION 1.64 • n=4 Participants
|
5.69 units on a scale
STANDARD_DEVIATION 1.54 • n=27 Participants
|
5.56 units on a scale
STANDARD_DEVIATION 1.54 • n=483 Participants
|
|
Weight
|
64.52 kilograms (kg)
STANDARD_DEVIATION 11.93 • n=93 Participants
|
62.72 kilograms (kg)
STANDARD_DEVIATION 13.35 • n=4 Participants
|
65.08 kilograms (kg)
STANDARD_DEVIATION 10.23 • n=27 Participants
|
64.21 kilograms (kg)
STANDARD_DEVIATION 11.9 • n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument 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 |
Placebo
n=167 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg and 60 mg Combined
n=171 Participants
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
|
Duloxetine 60 mg
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
|
-1.61 units on a scale
Standard Error 0.18
|
-2.47 units on a scale
Standard Error 0.18
|
—
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument 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 |
Placebo
n=167 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg and 60 mg Combined
n=85 Participants
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
|
Duloxetine 60 mg
n=86 Participants
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries
|
-1.61 units on a scale
Standard Error 0.19
|
-2.41 units on a scale
Standard Error 0.21
|
-2.53 units on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Placebo
n=167 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg and 60 mg Combined
n=171 Participants
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
|
Duloxetine 60 mg
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
Night Pain
|
-1.56 units on a scale
Standard Error 0.19
|
-2.39 units on a scale
Standard Error 0.19
|
—
|
|
Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
Worst Pain
|
-1.55 units on a scale
Standard Error 0.19
|
-2.51 units on a scale
Standard Error 0.19
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Placebo
n=167 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg and 60 mg Combined
n=85 Participants
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
|
Duloxetine 60 mg
n=86 Participants
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries
Worst Pain
|
-1.55 units on a scale
Standard Error 0.19
|
-2.42 units on a scale
Standard Error 0.22
|
-2.59 units on a scale
Standard Error 0.22
|
|
Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries
Night Pain
|
-1.56 units on a scale
Standard Error 0.19
|
-2.33 units on a scale
Standard Error 0.22
|
-2.45 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Week 12Population: Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Placebo
n=165 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg and 60 mg Combined
n=169 Participants
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
|
Duloxetine 60 mg
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)
|
3.18 units on a scale
Standard Error 0.12
|
2.53 units on a scale
Standard Error 0.12
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Placebo
n=165 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg and 60 mg Combined
n=84 Participants
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
|
Duloxetine 60 mg
n=85 Participants
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Patient Global Impression of Improvement Scale at Week 12
|
3.18 units on a scale
Standard Error 0.12
|
2.53 units on a scale
Standard Error 0.14
|
2.52 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.
Outcome measures
| Measure |
Placebo
n=165 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg and 60 mg Combined
n=169 Participants
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
|
Duloxetine 60 mg
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Worst Pain
|
-1.62 units on a scale
Standard Error 0.21
|
-2.59 units on a scale
Standard Error 0.21
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Least Pain
|
-1.13 units on a scale
Standard Error 0.21
|
-1.98 units on a scale
Standard Error 0.21
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Average Pain
|
-1.54 units on a scale
Standard Error 0.2
|
-2.54 units on a scale
Standard Error 0.2
|
—
|
|
Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Pain Right Now
|
-1.67 units on a scale
Standard Error 0.22
|
-2.59 units on a scale
Standard Error 0.22
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.
Outcome measures
| Measure |
Placebo
n=165 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg and 60 mg Combined
n=84 Participants
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
|
Duloxetine 60 mg
n=85 Participants
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory Severity Scores at Week 12
Worst Pain
|
-1.62 units on a scale
Standard Error 0.21
|
-2.51 units on a scale
Standard Error 0.25
|
-2.68 units on a scale
Standard Error 0.25
|
|
Change From Baseline in Brief Pain Inventory Severity Scores at Week 12
Least Pain
|
-1.13 units on a scale
Standard Error 0.21
|
-1.92 units on a scale
Standard Error 0.25
|
-2.04 units on a scale
Standard Error 0.25
|
|
Change From Baseline in Brief Pain Inventory Severity Scores at Week 12
Average Pain
|
-1.55 units on a scale
Standard Error 0.2
|
-2.53 units on a scale
Standard Error 0.23
|
-2.56 units on a scale
Standard Error 0.23
|
|
Change From Baseline in Brief Pain Inventory Severity Scores at Week 12
Pain Right Now
|
-1.67 units on a scale
Standard Error 0.22
|
-2.55 units on a scale
Standard Error 0.25
|
-2.62 units on a scale
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.
Outcome measures
| Measure |
Placebo
n=165 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg and 60 mg Combined
n=169 Participants
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
|
Duloxetine 60 mg
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
General Activity
|
-1.88 units on a scale
Standard Error 0.24
|
-2.29 units on a scale
Standard Error 0.24
|
—
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Mood
|
-1.91 units on a scale
Standard Error 0.24
|
-2.28 units on a scale
Standard Error 0.24
|
—
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Walking Ability
|
-1.82 units on a scale
Standard Error 0.23
|
-2.31 units on a scale
Standard Error 0.23
|
—
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Normal Work
|
-1.49 units on a scale
Standard Error 0.23
|
-1.86 units on a scale
Standard Error 0.23
|
—
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Relation to People
|
-0.77 units on a scale
Standard Error 0.23
|
-1.32 units on a scale
Standard Error 0.23
|
—
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Sleep
|
-1.69 units on a scale
Standard Error 0.24
|
-2.15 units on a scale
Standard Error 0.24
|
—
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Enjoyment of Life
|
-1.59 units on a scale
Standard Error 0.23
|
-2.15 units on a scale
Standard Error 0.23
|
—
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
Average of Interference Scores
|
-1.56 units on a scale
Standard Error 0.2
|
-2.04 units on a scale
Standard Error 0.2
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.
Outcome measures
| Measure |
Placebo
n=165 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg and 60 mg Combined
n=84 Participants
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
|
Duloxetine 60 mg
n=85 Participants
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12
Relation to People
|
-0.77 units on a scale
Standard Error 0.23
|
-1.16 units on a scale
Standard Error 0.27
|
-1.49 units on a scale
Standard Error 0.27
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12
General Activity
|
-1.88 units on a scale
Standard Error 0.24
|
-2.48 units on a scale
Standard Error 0.29
|
-2.1 units on a scale
Standard Error 0.29
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12
Mood
|
-1.91 units on a scale
Standard Error 0.24
|
-2.18 units on a scale
Standard Error 0.29
|
-2.39 units on a scale
Standard Error 0.29
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12
Walking Ability
|
-1.82 units on a scale
Standard Error 0.23
|
-2.32 units on a scale
Standard Error 0.28
|
-2.31 units on a scale
Standard Error 0.28
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12
Normal Work
|
-1.49 units on a scale
Standard Error 0.23
|
-1.84 units on a scale
Standard Error 0.28
|
-1.9 units on a scale
Standard Error 0.28
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12
Sleep
|
-1.69 units on a scale
Standard Error 0.24
|
-2.26 units on a scale
Standard Error 0.29
|
-2.05 units on a scale
Standard Error 0.29
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12
Enjoyment of Life
|
-1.59 units on a scale
Standard Error 0.23
|
-1.96 units on a scale
Standard Error 0.28
|
-2.35 units on a scale
Standard Error 0.28
|
|
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12
Average of Interference Scores
|
-1.56 units on a scale
Standard Error 0.2
|
-2 units on a scale
Standard Error 0.24
|
-2.08 units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
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 ranges from 0 (no depression) to 63 (severe depression).
Outcome measures
| Measure |
Placebo
n=165 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg and 60 mg Combined
n=169 Participants
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
|
Duloxetine 60 mg
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)
|
-3.27 units on a scale
Standard Error 0.64
|
-3.37 units on a scale
Standard Error 0.64
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.
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 ranges from 0 (no depression) to 63 (severe depression).
Outcome measures
| Measure |
Placebo
n=165 Participants
placebo comparator taken orally every day
|
Duloxetine 40 mg and 60 mg Combined
n=84 Participants
Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
|
Duloxetine 60 mg
n=85 Participants
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12
|
-3.28 units on a scale
Standard Error 0.65
|
-2.94 units on a scale
Standard Error 0.76
|
-3.83 units on a scale
Standard Error 0.77
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 121 other events
Deaths: 0 deaths
Duloxetine 40 mg
Serious events: 3 serious events
Other events: 71 other events
Deaths: 0 deaths
Duloxetine 60 mg
Serious events: 2 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=167 participants at risk
placebo comparator taken orally every day
|
Duloxetine 40 mg
n=85 participants at risk
Duloxetine 40 milligrams (mg) taken orally every day
|
Duloxetine 60 mg
n=86 participants at risk
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Infections and infestations
Arthritis bacterial
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/167
|
0.00%
0/85
|
1.2%
1/86 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Infections and infestations
Sepsis
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Infections and infestations
Tuberculous pleurisy
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/167
|
1.2%
1/85 • Number of events 1
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Back injury
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/167
|
1.2%
1/85 • Number of events 1
|
0.00%
0/86
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/167
|
1.2%
1/85 • Number of events 1
|
0.00%
0/86
|
|
Investigations
Blood alkaline phosphatase increased
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Investigations
Blood bilirubin increased
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Investigations
C-reactive protein increased
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Investigations
Platelet count increased
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/167
|
1.2%
1/85 • Number of events 1
|
0.00%
0/86
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Nervous system disorders
Cerebral infarction
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Nervous system disorders
Facial palsy
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Nervous system disorders
Hemiparesis
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/167
|
0.00%
0/85
|
1.2%
1/86 • Number of events 1
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Psychiatric disorders
Self injurious behaviour
|
0.00%
0/167
|
0.00%
0/85
|
1.2%
1/86 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.60%
1/167 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
Other adverse events
| Measure |
Placebo
n=167 participants at risk
placebo comparator taken orally every day
|
Duloxetine 40 mg
n=85 participants at risk
Duloxetine 40 milligrams (mg) taken orally every day
|
Duloxetine 60 mg
n=86 participants at risk
Duloxetine 60 milligrams (mg) taken orally every day
|
|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/167
|
4.7%
4/85 • Number of events 4
|
1.2%
1/86 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
5.4%
9/167 • Number of events 9
|
7.1%
6/85 • Number of events 6
|
5.8%
5/86 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
6/167 • Number of events 6
|
4.7%
4/85 • Number of events 5
|
8.1%
7/86 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
1.8%
3/167 • Number of events 3
|
11.8%
10/85 • Number of events 11
|
16.3%
14/86 • Number of events 17
|
|
Gastrointestinal disorders
Stomach discomfort
|
2.4%
4/167 • Number of events 4
|
3.5%
3/85 • Number of events 4
|
4.7%
4/86 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
2/167 • Number of events 2
|
4.7%
4/85 • Number of events 5
|
5.8%
5/86 • Number of events 7
|
|
General disorders
Malaise
|
1.8%
3/167 • Number of events 3
|
3.5%
3/85 • Number of events 3
|
7.0%
6/86 • Number of events 7
|
|
General disorders
Thirst
|
1.8%
3/167 • Number of events 3
|
4.7%
4/85 • Number of events 4
|
4.7%
4/86 • Number of events 4
|
|
Infections and infestations
Nasopharyngitis
|
14.4%
24/167 • Number of events 24
|
11.8%
10/85 • Number of events 11
|
16.3%
14/86 • Number of events 16
|
|
Investigations
Alanine aminotransferase increased
|
3.6%
6/167 • Number of events 6
|
5.9%
5/85 • Number of events 5
|
5.8%
5/86 • Number of events 5
|
|
Investigations
Aspartate aminotransferase increased
|
3.6%
6/167 • Number of events 6
|
5.9%
5/85 • Number of events 5
|
9.3%
8/86 • Number of events 8
|
|
Investigations
Blood alkaline phosphatase increased
|
0.60%
1/167 • Number of events 1
|
4.7%
4/85 • Number of events 4
|
2.3%
2/86 • Number of events 2
|
|
Investigations
Blood creatine phosphokinase increased
|
3.6%
6/167 • Number of events 6
|
7.1%
6/85 • Number of events 6
|
0.00%
0/86
|
|
Investigations
Blood glucose decreased
|
4.2%
7/167 • Number of events 15
|
2.4%
2/85 • Number of events 4
|
2.3%
2/86 • Number of events 2
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.4%
4/167 • Number of events 4
|
2.4%
2/85 • Number of events 2
|
5.8%
5/86 • Number of events 5
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.4%
4/167 • Number of events 4
|
2.4%
2/85 • Number of events 2
|
5.8%
5/86 • Number of events 5
|
|
Investigations
Glycosylated haemoglobin increased
|
2.4%
4/167 • Number of events 4
|
1.2%
1/85 • Number of events 1
|
5.8%
5/86 • Number of events 5
|
|
Investigations
White blood cell count increased
|
2.4%
4/167 • Number of events 4
|
4.7%
4/85 • Number of events 4
|
5.8%
5/86 • Number of events 5
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/167
|
1.2%
1/85 • Number of events 1
|
4.7%
4/86 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
1.2%
2/167 • Number of events 3
|
7.1%
6/85 • Number of events 8
|
4.7%
4/86 • Number of events 4
|
|
Nervous system disorders
Headache
|
3.6%
6/167 • Number of events 9
|
4.7%
4/85 • Number of events 4
|
2.3%
2/86 • Number of events 3
|
|
Nervous system disorders
Somnolence
|
8.4%
14/167 • Number of events 14
|
18.8%
16/85 • Number of events 16
|
24.4%
21/86 • Number of events 23
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.0%
5/167 • Number of events 5
|
4.7%
4/85 • Number of events 4
|
1.2%
1/86 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.60%
1/167 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
4.7%
4/86 • Number of events 4
|
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