Trial Outcomes & Findings for Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain (NCT NCT00433290)
NCT ID: NCT00433290
Last Updated: 2009-09-02
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). Changes are timepoint minus baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
256 participants
Primary outcome timeframe
Baseline, Week 4, Week 7, Week 13
Results posted on
2009-09-02
Participant Flow
Participant milestones
| Measure |
Duloxetine
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
128
|
|
Overall Study
COMPLETED
|
93
|
111
|
|
Overall Study
NOT COMPLETED
|
35
|
17
|
Reasons for withdrawal
| Measure |
Duloxetine
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
24
|
7
|
|
Overall Study
Lack of Efficacy
|
1
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Entry Criteria Not Met
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain
Baseline characteristics by cohort
| Measure |
Duloxetine
n=128 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=128 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.16 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
61.90 years
STANDARD_DEVIATION 9.20 • n=7 Participants
|
62.53 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
62 participants
n=5 Participants
|
65 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=5 Participants
|
23 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Nonsteroidal Anti-Inflammatory Drug (NSAID) Use
No
|
81 participants
n=5 Participants
|
75 participants
n=7 Participants
|
156 participants
n=5 Participants
|
|
Nonsteroidal Anti-Inflammatory Drug (NSAID) Use
Yes
|
47 participants
n=5 Participants
|
53 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Race/Ethnicity
African
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
126 participants
n=5 Participants
|
124 participants
n=7 Participants
|
250 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Body Mass Index
|
29.44 kilograms/meters squared
STANDARD_DEVIATION 4.66 • n=5 Participants
|
29.65 kilograms/meters squared
STANDARD_DEVIATION 4.52 • n=7 Participants
|
29.55 kilograms/meters squared
STANDARD_DEVIATION 4.58 • n=5 Participants
|
|
Body Weight
|
81.05 kilograms
STANDARD_DEVIATION 13.73 • n=5 Participants
|
80.55 kilograms
STANDARD_DEVIATION 12.24 • n=7 Participants
|
80.80 kilograms
STANDARD_DEVIATION 12.98 • n=5 Participants
|
|
Brief Pain Inventory Average Pain
|
6.07 units on a scale
STANDARD_DEVIATION 1.39 • n=5 Participants
|
6.14 units on a scale
STANDARD_DEVIATION 1.27 • n=7 Participants
|
6.11 units on a scale
STANDARD_DEVIATION 1.33 • n=5 Participants
|
|
Clinical Global Impressions of Severity Scale (CGI-S)
|
3.34 units on a scale
STANDARD_DEVIATION 1.21 • n=5 Participants
|
3.34 units on a scale
STANDARD_DEVIATION 1.33 • n=7 Participants
|
3.34 units on a scale
STANDARD_DEVIATION 1.27 • n=5 Participants
|
|
Duration of Osteoarthritis Pain Since Onset
|
8.14 years
STANDARD_DEVIATION 7.64 • n=5 Participants
|
6.74 years
STANDARD_DEVIATION 6.58 • n=7 Participants
|
7.44 years
STANDARD_DEVIATION 7.15 • n=5 Participants
|
|
Duration of Osteoarthritis Since Diagnosis
|
6.16 years
STANDARD_DEVIATION 5.88 • n=5 Participants
|
5.62 years
STANDARD_DEVIATION 6.20 • n=7 Participants
|
5.89 years
STANDARD_DEVIATION 6.04 • n=5 Participants
|
|
Height
|
165.99 centimeters
STANDARD_DEVIATION 8.69 • n=5 Participants
|
165.02 centimeters
STANDARD_DEVIATION 7.99 • n=7 Participants
|
165.51 centimeters
STANDARD_DEVIATION 8.34 • n=5 Participants
|
|
Weekly Mean of 24 Hour Average Pain Severity
|
6.02 units on a scale
STANDARD_DEVIATION 1.18 • n=5 Participants
|
6.07 units on a scale
STANDARD_DEVIATION 1.26 • n=7 Participants
|
6.04 units on a scale
STANDARD_DEVIATION 1.22 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 7, Week 13Population: All randomized participants. Intent-to-treat analysis.
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). Changes are timepoint minus baseline.
Outcome measures
| Measure |
Duloxetine
n=128 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=128 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change in Brief Pain Inventory (BPI) 24-hour Average Rating
Week 4 Change from Baseline (n=121, n=127)
|
-1.80 units on a scale
Standard Error 0.16
|
-1.12 units on a scale
Standard Error 0.15
|
|
Change in Brief Pain Inventory (BPI) 24-hour Average Rating
Week 7 Change from Baseline (n=106, n=119)
|
-2.47 units on a scale
Standard Error 0.18
|
-1.41 units on a scale
Standard Error 0.17
|
|
Change in Brief Pain Inventory (BPI) 24-hour Average Rating
Week 13 Change from Baseline (n=100, n=116)
|
-2.72 units on a scale
Standard Error 0.20
|
-1.88 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: 13 WeeksPopulation: All randomized participants with at least one non-missing post-baseline value.
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Duloxetine
n=123 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)
|
2.85 units on a scale
Standard Deviation 1.24
|
3.09 units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: All randomized participants with a baseline and at least one non-missing post-baseline value.
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).
Outcome measures
| Measure |
Duloxetine
n=118 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=126 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale
Baseline
|
35.05 units on a scale
Standard Deviation 9.63
|
36.82 units on a scale
Standard Deviation 8.15
|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale
Change from Baseline
|
-13.78 units on a scale
Standard Deviation 10.78
|
-10.75 units on a scale
Standard Deviation 10.98
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: All randomized participants with baseline and at least one non-missing post-baseline value.
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).
Outcome measures
| Measure |
Duloxetine
n=123 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
Baseline
|
10.24 units on a scale
Standard Deviation 2.47
|
10.35 units on a scale
Standard Deviation 2.66
|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
Change from Baseline
|
-4.27 units on a scale
Standard Deviation 3.30
|
-3.49 units on a scale
Standard Deviation 3.89
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: All randomized participants with baseline and at least one non-missing post-baseline value.
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).
Outcome measures
| Measure |
Duloxetine
n=123 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale
Baseline
|
4.27 units on a scale
Standard Deviation 1.36
|
4.50 units on a scale
Standard Deviation 1.34
|
|
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale
Change from Baseline
|
-1.63 units on a scale
Standard Deviation 1.66
|
-1.36 units on a scale
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: All randomized participants with a baseline and at least one non-missing post-baseline value.
This assesses the weekly mean of the average pain and worst pain experienced over the last 24-hours. This is an ordinal scale with scores for each subscale (average pain and worst pain) ranging from 0 (no pain) to 10 (worst possible pain). Change = endpoint minus baseline.
Outcome measures
| Measure |
Duloxetine
n=124 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=126 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores
Change in Weekly 24-Hour Average Pain
|
-2.39 units on a scale
Standard Deviation 1.90
|
-1.78 units on a scale
Standard Deviation 1.86
|
|
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores
Baseline Weekly 24-Hour Worst Pain
|
7.58 units on a scale
Standard Deviation 1.26
|
7.53 units on a scale
Standard Deviation 1.21
|
|
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores
Change in Weekly 24-Hour Worst Pain
|
-2.57 units on a scale
Standard Deviation 2.10
|
-2.05 units on a scale
Standard Deviation 1.90
|
|
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores
Baseline Weekly 24-Hour Average Pain
|
6.05 units on a scale
Standard Deviation 1.16
|
6.08 units on a scale
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: All randomized participants with a baseline and at least one non-missing post-baseline value.
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=123 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)
|
-0.63 units on a scale
Standard Deviation 0.95
|
-0.32 units on a scale
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: 13 WeeksPopulation: Number of randomized participants with non-missing response values.
Response to treatment was defined as a ≥ 30% reduction from baseline to endpoint in Brief Pain Inventory (BPI) average pain score. The BPI 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).
Outcome measures
| Measure |
Duloxetine
n=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Number of Participants Who Responded to Treatment at 13 Week Endpoint
|
79 participants
|
56 participants
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
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=128 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=128 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Mental Component Summary Baseline (n=119, n=121)
|
55.86 units on a scale
Standard Deviation 10.00
|
54.47 units on a scale
Standard Deviation 10.16
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Mental Component Summary Change from Baseline
|
0.35 units on a scale
Standard Deviation 8.11
|
1.10 units on a scale
Standard Deviation 8.30
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Physical Component Summary Baseline (n=119, n=121)
|
30.59 units on a scale
Standard Deviation 7.37
|
28.70 units on a scale
Standard Deviation 6.87
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Physical Component Summary Change from Baseline
|
7.26 units on a scale
Standard Deviation 8.55
|
4.76 units on a scale
Standard Deviation 7.93
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Bodily Pain Baseline (n=121, n=124)
|
5.77 units on a scale
Standard Deviation 1.25
|
5.58 units on a scale
Standard Deviation 1.22
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Bodily Pain Change from Baseline
|
1.64 units on a scale
Standard Deviation 1.70
|
1.12 units on a scale
Standard Deviation 1.76
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
General Health Baseline (n=120, n=122)
|
17.02 units on a scale
Standard Deviation 4.38
|
16.61 units on a scale
Standard Deviation 4.28
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
General Health Change from Baseline
|
1.15 units on a scale
Standard Deviation 2.96
|
0.64 units on a scale
Standard Deviation 3.18
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Mental Health Baseline (n=121, n=124)
|
24.13 units on a scale
Standard Deviation 4.06
|
23.67 units on a scale
Standard Deviation 4.17
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Mental Health Change from Baseline
|
0.64 units on a scale
Standard Deviation 3.31
|
0.56 units on a scale
Standard Deviation 3.46
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Physical Functioning Baseline (n=120, n=125)
|
17.48 units on a scale
Standard Deviation 3.90
|
16.38 units on a scale
Standard Deviation 3.58
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Physical Functioning Change from Baseline
|
2.95 units on a scale
Standard Deviation 4.17
|
2.16 units on a scale
Standard Deviation 3.76
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Role-Emotional Baseline (n=121, n=125)
|
5.05 units on a scale
Standard Deviation 1.19
|
4.76 units on a scale
Standard Deviation 1.26
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Role-Emotional Change from Baseline
|
0.35 units on a scale
Standard Deviation 1.22
|
0.40 units on a scale
Standard Deviation 1.22
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Role-Physical Baseline (n=121, n=125)
|
5.31 units on a scale
Standard Deviation 1.44
|
4.96 units on a scale
Standard Deviation 1.33
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Role-Physical Change from Baseline
|
1.03 units on a scale
Standard Deviation 1.80
|
0.70 units on a scale
Standard Deviation 1.66
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Social Functioning Baseline (n=121, n=125)
|
8.18 units on a scale
Standard Deviation 1.76
|
7.78 units on a scale
Standard Deviation 1.69
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Social Functioning Change from Baseline
|
0.44 units on a scale
Standard Deviation 1.63
|
0.44 units on a scale
Standard Deviation 1.74
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Vitality Baseline (n=121, n=124)
|
16.10 units on a scale
Standard Deviation 3.84
|
15.43 units on a scale
Standard Deviation 3.69
|
|
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores
Vitality Change from Baseline
|
1.04 units on a scale
Standard Deviation 3.46
|
0.81 units on a scale
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.
Outcome measures
| Measure |
Duloxetine
n=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=124 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)
Baseline
|
0.68 units on a scale
Standard Deviation 0.16
|
0.66 units on a scale
Standard Deviation 0.16
|
|
Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)
Change from Baseline
|
0.09 units on a scale
Standard Deviation 0.16
|
0.08 units on a scale
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: All randomized participants. Intent-to-treat analysis.
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=122 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)
Baseline
|
4.29 units on a scale
Standard Deviation 6.27
|
5.35 units on a scale
Standard Deviation 6.59
|
|
Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)
Change from Baseline
|
-0.82 units on a scale
Standard Deviation 4.23
|
-1.25 units on a scale
Standard Deviation 3.90
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
A 14-item questionnaire with 2 subscales: anxiety (7 items) and depression (7 items). Each item is rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety subscale. Scores of 11 or more 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=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=122 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Baseline
|
4.26 units on a scale
Standard Deviation 3.32
|
4.16 units on a scale
Standard Deviation 3.52
|
|
Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Change from Baseline
|
-1.11 units on a scale
Standard Deviation 2.36
|
-0.69 units on a scale
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
A self-reported scale that measures the severity of pain based on the worst pain experienced 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=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score
Baseline
|
7.49 units on a scale
Standard Deviation 1.51
|
7.50 units on a scale
Standard Deviation 1.33
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score
Change from Baseline
|
-2.74 units on a scale
Standard Deviation 2.22
|
-1.94 units on a scale
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
A self-reported scale that measures the severity of pain based on the least pain experienced 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=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score
Baseline
|
4.70 units on a scale
Standard Deviation 1.80
|
4.63 units on a scale
Standard Deviation 1.86
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score
Change from Baseline
|
-1.95 units on a scale
Standard Deviation 2.27
|
-1.24 units on a scale
Standard Deviation 2.40
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Number of randomized participants with a 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 experienced 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=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score
Baseline
|
6.09 units on a scale
Standard Deviation 1.38
|
6.16 units on a scale
Standard Deviation 1.26
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score
Change from Baseline
|
-2.54 units on a scale
Standard Deviation 1.99
|
-1.78 units on a scale
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Duloxetine
n=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score
Baseline
|
5.45 units on a scale
Standard Deviation 1.96
|
5.36 units on a scale
Standard Deviation 1.91
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score
Change from Baseline
|
-2.57 units on a scale
Standard Deviation 2.29
|
-1.80 units on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
A self-reported scale that measures the interference of pain in the past 24 hours for general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine
n=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=126 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity
Baseline
|
4.70 units on a scale
Standard Deviation 2.28
|
5.17 units on a scale
Standard Deviation 2.18
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity
Change from Baseline
|
-2.26 units on a scale
Standard Deviation 2.49
|
-1.92 units on a scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine
n=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=126 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood
Baseline
|
3.35 units on a scale
Standard Deviation 2.53
|
3.60 units on a scale
Standard Deviation 2.64
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood
Change from Baseline
|
-1.59 units on a scale
Standard Deviation 2.79
|
-1.72 units on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine
n=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=126 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability
Baseline
|
5.41 units on a scale
Standard Deviation 2.26
|
5.54 units on a scale
Standard Deviation 2.20
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability
Change from Baseline
|
-2.63 units on a scale
Standard Deviation 2.58
|
-2.07 units on a scale
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine
n=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=126 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work
Baseline
|
4.77 units on a scale
Standard Deviation 2.39
|
4.88 units on a scale
Standard Deviation 2.26
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work
Change from Baseline
|
-2.43 units on a scale
Standard Deviation 2.49
|
-1.56 units on a scale
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine
n=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=126 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People
Baseline
|
2.36 units on a scale
Standard Deviation 2.53
|
2.37 units on a scale
Standard Deviation 2.35
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People
Change from Baseline
|
-1.16 units on a scale
Standard Deviation 2.62
|
-0.89 units on a scale
Standard Deviation 2.15
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine
n=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=126 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep
Baseline
|
3.66 units on a scale
Standard Deviation 2.73
|
4.02 units on a scale
Standard Deviation 2.73
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep
Change from Baseline
|
-1.91 units on a scale
Standard Deviation 2.74
|
-1.91 units on a scale
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine
n=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=126 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life
Baseline
|
3.10 units on a scale
Standard Deviation 2.78
|
3.29 units on a scale
Standard Deviation 2.73
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life
Change from Baseline
|
-1.53 units on a scale
Standard Deviation 2.74
|
-1.23 units on a scale
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: The number of randomized participants with a baseline and at least one non-missing post-baseline value.
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Duloxetine
n=121 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=126 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference
Baseline
|
3.91 units on a scale
Standard Deviation 1.98
|
4.13 units on a scale
Standard Deviation 1.95
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference
Change from Baseline
|
-1.93 units on a scale
Standard Deviation 2.05
|
-1.62 units on a scale
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: over 13 weeksPopulation: All randomized participants.
Outcome measures
| Measure |
Duloxetine
n=128 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=128 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Adverse Events Reported as Reason for Discontinuation
Nausea
|
5 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Insomnia
|
1 participants
|
2 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Arthralgia
|
2 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Asthenia
|
2 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Constipation
|
1 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Abdominal pain upper
|
0 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Abnormal dreams
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Anxiety
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Atrial fibrillation
|
0 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Diarrhoea
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Drug intolerance
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Dyspepsia
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Ejaculation disorder
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Erectile dysfunction
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Haemorrhoids
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Hot flush
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Lethargy
|
0 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Memory impairment
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Palpitations
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Pyelonephritis acute
|
0 participants
|
1 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Sleep disorder
|
1 participants
|
0 participants
|
|
Adverse Events Reported as Reason for Discontinuation
Supraventricular tachycardia
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Number of participants with a baseline and at least one non-missing post-baseline value.
Outcome measures
| Measure |
Duloxetine
n=128 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=128 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes
Alkaline Phosphatase Change from Baseline
|
2.38 Units/Liter
Standard Deviation 15.74
|
-3.43 Units/Liter
Standard Deviation 14.56
|
|
Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes
Alkaline Phosphatase Baseline (n=120,n=126)
|
77.33 Units/Liter
Standard Deviation 22.91
|
75.90 Units/Liter
Standard Deviation 22.30
|
|
Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes
Aspartate Amino Transaminase (AST) Baseline
|
22.61 Units/Liter
Standard Deviation 7.89
|
24.23 Units/Liter
Standard Deviation 11.10
|
|
Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes
AST Change from Baseline (n=117,n=124)
|
1.44 Units/Liter
Standard Deviation 8.32
|
-1.37 Units/Liter
Standard Deviation 7.26
|
|
Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes
Gammaglutamyl Transpeptidase (GGT) Baseline
|
25.56 Units/Liter
Standard Deviation 17.56
|
30.55 Units/Liter
Standard Deviation 30.72
|
|
Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes
GGT Change from Baseline (n=120,n=126)
|
5.33 Units/Liter
Standard Deviation 20.40
|
-2.10 Units/Liter
Standard Deviation 19.12
|
SECONDARY outcome
Timeframe: Baseline and 13 Week EndpointPopulation: Number of randomized participants with a baseline and at least one non-missing post-baseline value.
Outcome measures
| Measure |
Duloxetine
n=120 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=126 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride
Baseline
|
104.38 millimole per Liter
Standard Deviation 2.26
|
104.18 millimole per Liter
Standard Deviation 2.43
|
|
Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride
Change from Baseline
|
-0.83 millimole per Liter
Standard Deviation 2.62
|
-0.08 millimole per Liter
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Number of participants with a baseline and at least one non-missing post-baseline value.
Outcome measures
| Measure |
Duloxetine
n=123 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate
Baseline
|
68.74 beats per minute
Standard Deviation 6.72
|
69.73 beats per minute
Standard Deviation 7.76
|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate
Change from Baseline
|
2.55 beats per minute
Standard Deviation 7.22
|
0.06 beats per minute
Standard Deviation 6.47
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Number of participants with a baseline and at least one non-missing post-baseline value.
Outcome measures
| Measure |
Duloxetine
n=123 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure
Systolic Blood Pressure (SBP) Baseline
|
132.20 mm Hg
Standard Deviation 13.75
|
131.42 mm Hg
Standard Deviation 16.13
|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure
SBP Change from Baseline
|
-1.03 mm Hg
Standard Deviation 11.45
|
0.89 mm Hg
Standard Deviation 12.93
|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure
Diastolic Blood Pressure (DBP) Baseline
|
79.73 mm Hg
Standard Deviation 8.27
|
79.83 mm Hg
Standard Deviation 9.26
|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure
DBP Change from Baseline
|
0.09 mm Hg
Standard Deviation 7.99
|
0.45 mm Hg
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Number of participants with a baseline and at least one non-missing post-baseline value.
Outcome measures
| Measure |
Duloxetine
n=123 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
n=127 Participants
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Weight
Baseline
|
81.01 kilograms
Standard Deviation 13.63
|
80.49 kilograms
Standard Deviation 12.27
|
|
Change From Baseline to 13 Week Endpoint in Vital Signs - Weight
Change from Baseline
|
-0.65 kilograms
Standard Deviation 2.01
|
0.47 kilograms
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Baseline and 13 WeeksPopulation: Number of participants who did not respond to treatment after 6 weeks of treatment.
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). Non-Responders were defined as patients with a \<30% reduction from baseline to visit 4 (7 weeks) in Brief Pain Inventory (BPI) average pain score.
Outcome measures
| Measure |
Duloxetine
n=33 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders
Baseline
|
5.30 units on a scale
Standard Deviation 1.61
|
—
|
|
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders
Change from Baseline
|
-0.76 units on a scale
Standard Deviation 2.03
|
—
|
SECONDARY outcome
Timeframe: 13 WeeksPopulation: Number of randomized participants who were non-responders at Visit 4 (7 weeks) and with non-missing response values.
Response was defined as a \>=30% reduction from baseline to endpoint in Brief Pain Inventory average pain score. Nonresponders were defined as participants with a \<30% reduction from baseline to Visit 4 (7 Weeks) in Brief Pain Inventory average pain score.
Outcome measures
| Measure |
Duloxetine
n=33 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint
|
9 participants
|
—
|
SECONDARY outcome
Timeframe: over 13 WeeksPopulation: Number of randomized participants who were nonresponders at Visit 4 (7 weeks).
Nonresponders were defined as participants with a \<30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score.
Outcome measures
| Measure |
Duloxetine
n=33 Participants
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Adverse Events Reported as Reason for Discontinuation in Nonresponders
Arthralgia
|
1 participants
|
—
|
|
Adverse Events Reported as Reason for Discontinuation in Nonresponders
Constipation
|
1 participants
|
—
|
|
Adverse Events Reported as Reason for Discontinuation in Nonresponders
Nausea
|
1 participants
|
—
|
Adverse Events
Duloxetine
Serious events: 3 serious events
Other events: 64 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duloxetine
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/128
|
0.78%
1/128 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.78%
1/128 • Number of events 1
|
0.00%
0/128
|
|
General disorders
Drug intolerance
|
0.78%
1/128 • Number of events 1
|
0.00%
0/128
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/128
|
0.78%
1/128 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
0.78%
1/128 • Number of events 1
|
0.00%
0/128
|
Other adverse events
| Measure |
Duloxetine
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
|
Placebo
placebo every day (QD), by mouth (PO) for 13 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.6%
2/128 • Number of events 2
|
0.00%
0/128
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.7%
6/128 • Number of events 6
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
8.6%
11/128 • Number of events 14
|
1.6%
2/128 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
6/128 • Number of events 7
|
2.3%
3/128 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth
|
4.7%
6/128 • Number of events 6
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
2/128 • Number of events 3
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
3/128 • Number of events 3
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
10.2%
13/128 • Number of events 14
|
2.3%
3/128 • Number of events 3
|
|
General disorders
Asthenia
|
3.1%
4/128 • Number of events 5
|
0.00%
0/128
|
|
General disorders
Fatigue
|
2.3%
3/128 • Number of events 3
|
0.78%
1/128 • Number of events 1
|
|
General disorders
Pyrexia
|
2.3%
3/128 • Number of events 3
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
1.6%
2/128 • Number of events 2
|
0.00%
0/128
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/128
|
1.6%
2/128 • Number of events 2
|
|
Infections and infestations
Influenza
|
1.6%
2/128 • Number of events 2
|
1.6%
2/128 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
3/128 • Number of events 3
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/128
|
1.6%
2/128 • Number of events 2
|
|
Investigations
Blood potassium increased
|
1.6%
2/128 • Number of events 2
|
1.6%
2/128 • Number of events 2
|
|
Investigations
Weight decreased
|
1.6%
2/128 • Number of events 2
|
0.00%
0/128
|
|
Metabolism and nutrition disorders
Anorexia
|
2.3%
3/128 • Number of events 3
|
0.00%
0/128
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
4/128 • Number of events 4
|
3.1%
4/128 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
3/128 • Number of events 3
|
1.6%
2/128 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.78%
1/128 • Number of events 1
|
1.6%
2/128 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
2/128 • Number of events 2
|
0.00%
0/128
|
|
Nervous system disorders
Dizziness
|
5.5%
7/128 • Number of events 9
|
1.6%
2/128 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
3.1%
4/128 • Number of events 4
|
0.78%
1/128 • Number of events 1
|
|
Nervous system disorders
Headache
|
3.1%
4/128 • Number of events 4
|
3.9%
5/128 • Number of events 6
|
|
Nervous system disorders
Somnolence
|
3.9%
5/128 • Number of events 6
|
2.3%
3/128 • Number of events 3
|
|
Nervous system disorders
Tremor
|
1.6%
2/128 • Number of events 2
|
0.00%
0/128
|
|
Psychiatric disorders
Abnormal dreams
|
1.6%
2/128 • Number of events 2
|
0.00%
0/128
|
|
Psychiatric disorders
Anxiety
|
1.6%
2/128 • Number of events 2
|
0.00%
0/128
|
|
Psychiatric disorders
Insomnia
|
4.7%
6/128 • Number of events 7
|
2.3%
3/128 • Number of events 3
|
|
Psychiatric disorders
Sleep disorder
|
1.6%
2/128 • Number of events 2
|
0.00%
0/128
|
|
Renal and urinary disorders
Dysuria
|
1.6%
2/128 • Number of events 2
|
0.00%
0/128
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
1.6%
2/128 • Number of events 2
|
0.00%
0/128
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.3%
3/128 • Number of events 3
|
0.00%
0/128
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
2/128 • Number of events 2
|
1.6%
2/128 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.5%
7/128 • Number of events 7
|
0.00%
0/128
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/128
|
1.6%
2/128 • Number of events 2
|
|
Vascular disorders
Hot flush
|
1.6%
2/128 • Number of events 2
|
0.00%
0/128
|
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