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CompletedNCT00433290Updated Sep 2, 2009Results posted

Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

A Phase 3 interventional study of Duloxetine and Placebo in Osteoarthritis Knee Pain, sponsored by Eli Lilly and Company. Completed at 7 sites in 4 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2009-09-02.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.

02

Conditions studied

  • Osteoarthritis Knee Pain
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 256 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female outpatients with osteoarthritis knee pain.

Exclusion criteria

Exclusion Criteria:

  • Serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
  • Previous exposure to duloxetine.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
256 participants (actual)

Study arms

  • Experimental
    A

    Drug: Duloxetine

  • Placebo comparator
    B

    Drug: Placebo

Interventions

  • DrugDuloxetine

    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

    Also known as: LY248686, Cymbalta

  • DrugPlacebo

    placebo every day (QD), by mouth (PO) for 13 weeks

06

What researchers measure

Primary outcomes

  1. Change in Brief Pain Inventory (BPI) 24-hour Average Rating

    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.

    Time frame: Baseline, Week 4, Week 7, Week 13

Secondary outcomes

  1. Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)

    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).

    Time frame: 13 Weeks

  2. Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale

    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).

    Time frame: Baseline and 13 Weeks

  3. Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale

    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).

    Time frame: Baseline and 13 Weeks

  4. Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale

    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).

    Time frame: Baseline and 13 Weeks

  5. Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores

    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.

    Time frame: Baseline and 13 Weeks

  6. Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)

    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.

    Time frame: Baseline and 13 Weeks

  7. Number of Participants Who Responded to Treatment at 13 Week Endpoint

    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).

    Time frame: 13 Weeks

  8. 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

    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.

    Time frame: Baseline and 13 Weeks

  9. Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)

    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.

    Time frame: Baseline and 13 Weeks

  10. Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)

    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.

    Time frame: Baseline and 13 Weeks

  11. Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)

    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.'

    Time frame: Baseline and 13 Weeks

  12. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score

    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).

    Time frame: Baseline and 13 Weeks

  13. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score

    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).

    Time frame: Baseline and 13 Weeks

  14. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score

    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).

    Time frame: Baseline and 13 Weeks

  15. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score

    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).

    Time frame: Baseline and 13 Weeks

  16. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity

    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).

    Time frame: Baseline and 13 Weeks

  17. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood

    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).

    Time frame: Baseline and 13 Weeks

  18. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability

    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).

    Time frame: Baseline and 13 Weeks

  19. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work

    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).

    Time frame: Baseline and 13 Weeks

  20. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People

    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).

    Time frame: Baseline and 13 Weeks

  21. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep

    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).

    Time frame: Baseline and 13 Weeks

  22. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life

    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).

    Time frame: Baseline and 13 Weeks

  23. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference

    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).

    Time frame: Baseline and 13 Weeks

  24. Adverse Events Reported as Reason for Discontinuation

    Time frame: over 13 weeks

  25. Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes

    Time frame: Baseline and 13 Weeks

  26. Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride

    Time frame: Baseline and 13 Week Endpoint

  27. Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate

    Time frame: Baseline and 13 Weeks

  28. Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure

    Time frame: Baseline and 13 Weeks

  29. Change From Baseline to 13 Week Endpoint in Vital Signs - Weight

    Time frame: Baseline and 13 Weeks

  30. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders

    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.

    Time frame: Baseline and 13 Weeks

  31. Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint

    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.

    Time frame: 13 Weeks

  32. Adverse Events Reported as Reason for Discontinuation in Nonresponders

    Nonresponders were defined as participants with a \<30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score.

    Time frame: over 13 Weeks

07

Results

Posted Aug 24, 2009

Participant flow

Participant flow — Overall Study
MilestoneDuloxetinePlacebo
Started128128
Completed93111
Not completed3517
Withdrew: Adverse event247
Withdrew: Lack of efficacy15
Withdrew: Withdrawal by subject42
Withdrew: Protocol violation32
Withdrew: Physician decision20
Withdrew: Entry criteria not met01
Withdrew: Lost to follow-up10

Outcome measures

PrimaryChange in Brief Pain Inventory (BPI) 24-hour Average Rating

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.

Time frame:
Baseline, Week 4, Week 7, Week 13
Reported as:
Least squares mean · units on a scale
Change in Brief Pain Inventory (BPI) 24-hour Average Rating
units on a scaleDuloxetinePlacebo
Week 4 Change from Baseline (n=121, n=127)-1.80 ± 0.16-1.12 ± 0.15
Week 7 Change from Baseline (n=106, n=119)-2.47 ± 0.18-1.41 ± 0.17
Week 13 Change from Baseline (n=100, n=116)-2.72 ± 0.20-1.88 ± 0.18
Statistical analysis
  • Duloxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value for Week 4 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.)Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit
  • Duloxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value for Week 7 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.)Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit
  • Duloxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value for Week 13 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.)Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit
SecondaryMean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)

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).

Time frame:
13 Weeks
Reported as:
Mean · units on a scale
Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)
units on a scaleDuloxetinePlacebo
Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)2.85 ± 1.243.09 ± 1.08
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.164Model: PGI-Improvement=Treatment, Pooled Investigator, baseline severity and NSAID used for main effect p-values.
SecondaryChange From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale
units on a scaleDuloxetinePlacebo
Baseline35.05 ± 9.6336.82 ± 8.15
Change from Baseline-13.78 ± 10.78-10.75 ± 10.98
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.016 (P-value for Change from Baseline (change = endpoint - baseline))Model: Change=Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.
SecondaryChange From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
units on a scaleDuloxetinePlacebo
Baseline10.24 ± 2.4710.35 ± 2.66
Change from Baseline-4.27 ± 3.30-3.49 ± 3.89
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.068 (P-value for Change from Baseline. Change = Week 13 value minus baseline value.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.
SecondaryChange From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale
units on a scaleDuloxetinePlacebo
Baseline4.27 ± 1.364.50 ± 1.34
Change from Baseline-1.63 ± 1.66-1.36 ± 1.71
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.064 (P-value for Change from Baseline. Change = Week 13 value minus baseline value.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.
SecondaryChange From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores

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.

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores
units on a scaleDuloxetinePlacebo
Baseline Weekly 24-Hour Average Pain6.05 ± 1.166.08 ± 1.26
Change in Weekly 24-Hour Average Pain-2.39 ± 1.90-1.78 ± 1.86
Baseline Weekly 24-Hour Worst Pain7.58 ± 1.267.53 ± 1.21
Change in Weekly 24-Hour Worst Pain-2.57 ± 2.10-2.05 ± 1.90
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.008 (P-value for Change in Weekly 24-Hour Average Pain. Change = endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.
  • Duloxetine vs Placebo · ANCOVA · p = 0.047 (P-value for Change in Weekly 24-Hour Worst Pain. Change = Endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.
SecondaryChange From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)

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.

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)
units on a scaleDuloxetinePlacebo
Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)-0.63 ± 0.95-0.32 ± 1.32
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.009Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.
SecondaryNumber of Participants Who Responded to Treatment at 13 Week Endpoint

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).

Time frame:
13 Weeks
Reported as:
Number · participants
Number of Participants Who Responded to Treatment at 13 Week Endpoint
participantsDuloxetinePlacebo
Number of Participants Who Responded to Treatment at 13 Week Endpoint7956
Statistical analysis
  • Duloxetine vs Placebo · Fisher Exact · p = <0.001
SecondaryMean 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

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.

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
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
units on a scaleDuloxetinePlacebo
Mental Component Summary Baseline (n=119, n=121)55.86 ± 10.0054.47 ± 10.16
Mental Component Summary Change from Baseline0.35 ± 8.111.10 ± 8.30
Physical Component Summary Baseline (n=119, n=121)30.59 ± 7.3728.70 ± 6.87
Physical Component Summary Change from Baseline7.26 ± 8.554.76 ± 7.93
Bodily Pain Baseline (n=121, n=124)5.77 ± 1.255.58 ± 1.22
Bodily Pain Change from Baseline1.64 ± 1.701.12 ± 1.76
General Health Baseline (n=120, n=122)17.02 ± 4.3816.61 ± 4.28
General Health Change from Baseline1.15 ± 2.960.64 ± 3.18
Mental Health Baseline (n=121, n=124)24.13 ± 4.0623.67 ± 4.17
Mental Health Change from Baseline0.64 ± 3.310.56 ± 3.46
Physical Functioning Baseline (n=120, n=125)17.48 ± 3.9016.38 ± 3.58
Physical Functioning Change from Baseline2.95 ± 4.172.16 ± 3.76
Role-Emotional Baseline (n=121, n=125)5.05 ± 1.194.76 ± 1.26
Role-Emotional Change from Baseline0.35 ± 1.220.40 ± 1.22
Role-Physical Baseline (n=121, n=125)5.31 ± 1.444.96 ± 1.33
Role-Physical Change from Baseline1.03 ± 1.800.70 ± 1.66
Social Functioning Baseline (n=121, n=125)8.18 ± 1.767.78 ± 1.69
Social Functioning Change from Baseline0.44 ± 1.630.44 ± 1.74
Vitality Baseline (n=121, n=124)16.10 ± 3.8415.43 ± 3.69
Vitality Change from Baseline1.04 ± 3.460.81 ± 3.03
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.897 (P-value for Mental Component Summary Change from Baseline. Change = Endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.
  • Duloxetine vs Placebo · ANCOVA · p = <0.001 (P-value for Physical Component Summary Change from Baseline. Change = Endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.
  • Duloxetine vs Placebo · ANCOVA · p = 0.004 (P-value for Bodily Pain Change from Baseline. Change = Endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.
  • Duloxetine vs Placebo · ANCOVA · p = 0.051 (P-value for General Health Change from Baseline. Change = Endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.
  • Duloxetine vs Placebo · ANCOVA · p = 0.508 (P-value for Mental Health Change from Baseline. Change = Endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.
  • Duloxetine vs Placebo · ANCOVA · p = 0.019 (P-value for Physical Functioning Change from Baseline. Change = Endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.
  • Duloxetine vs Placebo · ANCOVA · p = 0.415 (P-value for Role-Emotional Change from Baseline. Change = Endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.
  • Duloxetine vs Placebo · ANCOVA · p = 0.006 (P-value for Role-Physical Change from Baseline. Change = Endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.
  • Duloxetine vs Placebo · ANCOVA · p = 0.342 (P-value for Social Functioning Change from Baseline. Change = Endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.
  • Duloxetine vs Placebo · ANCOVA · p = 0.135 (P-value for Vitality Change from Baseline. Change = Endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.
SecondaryChange From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)

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.

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)
units on a scaleDuloxetinePlacebo
Baseline0.68 ± 0.160.66 ± 0.16
Change from Baseline0.09 ± 0.160.08 ± 0.18
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.209 (P-value for EQ-5D Change from Baseline. Change = Endpoint minus baseline.)Model: Change=Treament, Pooled Investigator, NSAID use and Baseline for main effect p-value.
SecondaryChange From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)

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.

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)
units on a scaleDuloxetinePlacebo
Baseline4.29 ± 6.275.35 ± 6.59
Change from Baseline-0.82 ± 4.23-1.25 ± 3.90
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.871 (P-value for Change from Baseline. Change = Week 13 value minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.
SecondaryChange From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)

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.'

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
units on a scaleDuloxetinePlacebo
Baseline4.26 ± 3.324.16 ± 3.52
Change from Baseline-1.11 ± 2.36-0.69 ± 2.44
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.138 (P-value for Change from Baseline. Change = Endpoint minus baseline.)Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score
units on a scaleDuloxetinePlacebo
Baseline7.49 ± 1.517.50 ± 1.33
Change from Baseline-2.74 ± 2.22-1.94 ± 2.29
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.003 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score
units on a scaleDuloxetinePlacebo
Baseline4.70 ± 1.804.63 ± 1.86
Change from Baseline-1.95 ± 2.27-1.24 ± 2.40
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.015 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score
units on a scaleDuloxetinePlacebo
Baseline6.09 ± 1.386.16 ± 1.26
Change from Baseline-2.54 ± 1.99-1.78 ± 2.10
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = <0.001 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
  • Duloxetine vs Placebo · Regression, Linear · p = 0.002 (P-value for direct analgesic effect. The null hypothesis was tested by testing a1=0 versus a1≠0.)
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score
units on a scaleDuloxetinePlacebo
Baseline5.45 ± 1.965.36 ± 1.91
Change from Baseline-2.57 ± 2.29-1.80 ± 2.39
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.007 (P-value for Change from Baseline. Change=Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity
units on a scaleDuloxetinePlacebo
Baseline4.70 ± 2.285.17 ± 2.18
Change from Baseline-2.26 ± 2.49-1.92 ± 2.34
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.050 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood
units on a scaleDuloxetinePlacebo
Baseline3.35 ± 2.533.60 ± 2.64
Change from Baseline-1.59 ± 2.79-1.72 ± 2.58
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.913 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability
units on a scaleDuloxetinePlacebo
Baseline5.41 ± 2.265.54 ± 2.20
Change from Baseline-2.63 ± 2.58-2.07 ± 2.61
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.066 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work
units on a scaleDuloxetinePlacebo
Baseline4.77 ± 2.394.88 ± 2.26
Change from Baseline-2.43 ± 2.49-1.56 ± 2.53
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.001 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People
units on a scaleDuloxetinePlacebo
Baseline2.36 ± 2.532.37 ± 2.35
Change from Baseline-1.16 ± 2.62-0.89 ± 2.15
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.260 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep
units on a scaleDuloxetinePlacebo
Baseline3.66 ± 2.734.02 ± 2.73
Change from Baseline-1.91 ± 2.74-1.91 ± 2.77
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.489 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life
units on a scaleDuloxetinePlacebo
Baseline3.10 ± 2.783.29 ± 2.73
Change from Baseline-1.53 ± 2.74-1.23 ± 2.73
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.131 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference

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).

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference
units on a scaleDuloxetinePlacebo
Baseline3.91 ± 1.984.13 ± 1.95
Change from Baseline-1.93 ± 2.05-1.62 ± 1.99
Statistical analysis
  • Duloxetine vs Placebo · ANCOVA · p = 0.082 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryAdverse Events Reported as Reason for Discontinuation
Time frame:
over 13 weeks
Reported as:
Number · participants
Adverse Events Reported as Reason for Discontinuation
participantsDuloxetinePlacebo
Nausea50
Insomnia12
Arthralgia20
Asthenia20
Constipation11
Abdominal pain upper01
Abnormal dreams10
Anxiety10
Atrial fibrillation01
Diarrhoea10
Drug intolerance10
Dyspepsia10
Ejaculation disorder10
Erectile dysfunction10
Haemorrhoids10
Hot flush10
Lethargy01
Memory impairment10
Palpitations10
Pyelonephritis acute01
Sleep disorder10
Supraventricular tachycardia10
SecondaryStatisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes
Time frame:
Baseline and 13 Weeks
Reported as:
Mean · Units/Liter
Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes
Units/LiterDuloxetinePlacebo
Alkaline Phosphatase Baseline (n=120,n=126)77.33 ± 22.9175.90 ± 22.30
Alkaline Phosphatase Change from Baseline2.38 ± 15.74-3.43 ± 14.56
Aspartate Amino Transaminase (AST) Baseline22.61 ± 7.8924.23 ± 11.10
AST Change from Baseline (n=117,n=124)1.44 ± 8.32-1.37 ± 7.26
Gammaglutamyl Transpeptidase (GGT) Baseline25.56 ± 17.5630.55 ± 30.72
GGT Change from Baseline (n=120,n=126)5.33 ± 20.40-2.10 ± 19.12
Statistical analysis
  • Duloxetine vs Placebo · ANOVA · p = <0.001 (P-value for Alkaline Phosphatase Change from Baseline. Change = Endpoint minus baseline.)
  • Duloxetine vs Placebo · ANOVA · p = 0.010 (P-value for AST Change from Baseline. Change = Endpoint minus baseline.)
  • Duloxetine vs Placebo · ANOVA · p = 0.023 (P-value for GGT Change from Baseline. Change = Endpoint minus baseline.)
SecondaryStatisically Significant Change From Baseline to 13 Week Endpoint in Chloride
Time frame:
Baseline and 13 Week Endpoint
Reported as:
Mean · millimole per Liter
Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride
millimole per LiterDuloxetinePlacebo
Baseline104.38 ± 2.26104.18 ± 2.43
Change from Baseline-0.83 ± 2.62-0.08 ± 2.66
Statistical analysis
  • Duloxetine vs Placebo · ANOVA · p = 0.042 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate
Time frame:
Baseline and 13 Weeks
Reported as:
Mean · beats per minute
Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate
beats per minuteDuloxetinePlacebo
Baseline68.74 ± 6.7269.73 ± 7.76
Change from Baseline2.55 ± 7.220.06 ± 6.47
Statistical analysis
  • Duloxetine vs Placebo · ANOVA · p = 0.005 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure
Time frame:
Baseline and 13 Weeks
Reported as:
Mean · mm Hg
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure
mm HgDuloxetinePlacebo
Systolic Blood Pressure (SBP) Baseline132.20 ± 13.75131.42 ± 16.13
SBP Change from Baseline-1.03 ± 11.450.89 ± 12.93
Diastolic Blood Pressure (DBP) Baseline79.73 ± 8.2779.83 ± 9.26
DBP Change from Baseline0.09 ± 7.990.45 ± 7.95
Statistical analysis
  • Duloxetine vs Placebo · ANOVA · p = 0.285 (P-value for SBP Change from Baseline. Change = Endpoint minus baseline.)
  • Duloxetine vs Placebo · ANOVA · p = 0.668 (P-value for DBP Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Vital Signs - Weight
Time frame:
Baseline and 13 Weeks
Reported as:
Mean · kilograms
Change From Baseline to 13 Week Endpoint in Vital Signs - Weight
kilogramsDuloxetinePlacebo
Baseline81.01 ± 13.6380.49 ± 12.27
Change from Baseline-0.65 ± 2.010.47 ± 1.94
Statistical analysis
  • Duloxetine vs Placebo · ANOVA · p = <0.001 (P-value for Change from Baseline. Change = Endpoint minus baseline.)
SecondaryChange From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders

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.

Time frame:
Baseline and 13 Weeks
Reported as:
Mean · units on a scale
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders
units on a scaleDuloxetine
Baseline5.30 ± 1.61
Change from Baseline-0.76 ± 2.03
Statistical analysis
  • Duloxetine · t-test, 2 sided · p = 0.040
SecondaryNumber of Nonresponders at Week 7 Who Responded at Week 13 Endpoint

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.

Time frame:
13 Weeks
Reported as:
Number · participants
Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint
participantsDuloxetine
Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint9
SecondaryAdverse Events Reported as Reason for Discontinuation in Nonresponders

Nonresponders were defined as participants with a \<30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score.

Time frame:
over 13 Weeks
Reported as:
Number · participants
Adverse Events Reported as Reason for Discontinuation in Nonresponders
participantsDuloxetine
Arthralgia1
Constipation1
Nausea1

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Duloxetine———
Placebo———
Most frequent serious events
Most frequent serious events
EventDuloxetinePlacebo
Atrial fibrillationCardiac disorders0/1281/128
Supraventricular tachycardiaCardiac disorders1/1280/128
Drug intoleranceGeneral disorders1/1280/128
Pyelonephritis acuteInfections and infestations0/1281/128
Memory impairmentNervous system disorders1/1280/128
Most frequent other events
Showing 10 of 39
Most frequent other events
EventDuloxetinePlacebo
NauseaGastrointestinal disorders13/1283/128
ConstipationGastrointestinal disorders11/1282/128
DizzinessNervous system disorders7/1282/128
HyperhidrosisSkin and subcutaneous tissue disorders7/1280/128
Abdominal pain upperGastrointestinal disorders6/1281/128
DiarrhoeaGastrointestinal disorders6/1283/128
Dry mouthGastrointestinal disorders6/1281/128
InsomniaPsychiatric disorders6/1283/128
HeadacheNervous system disorders4/1285/128
SomnolenceNervous system disorders5/1283/128

Baseline characteristics

Age Continuous
Age Continuous(years)DuloxetinePlaceboTotal
Mean63.16 ± 8.7561.90 ± 9.2062.53 ± 8.98
Sex: Female, Male
Sex: Female, Male(Participants)DuloxetinePlaceboTotal
Female89107196
Male392160
Region of Enrollment
Region of Enrollment(participants)DuloxetinePlaceboTotal
United States111021
Greece161632
Russian Federation6265127
Sweden141428
Canada252348
Nonsteroidal Anti-Inflammatory Drug (NSAID) Use
Nonsteroidal Anti-Inflammatory Drug (NSAID) Use(participants)DuloxetinePlaceboTotal
No8175156
Yes4753100
Race/Ethnicity
Race/Ethnicity(participants)DuloxetinePlaceboTotal
African033
Caucasian126124250
East Asian011
Hispanic202
Body Mass Index
Body Mass Index(kilograms/meters squared)DuloxetinePlaceboTotal
Mean29.44 ± 4.6629.65 ± 4.5229.55 ± 4.58
Body Weight
Body Weight(kilograms)DuloxetinePlaceboTotal
Mean81.05 ± 13.7380.55 ± 12.2480.80 ± 12.98
Brief Pain Inventory Average Pain
Brief Pain Inventory Average Pain(units on a scale)DuloxetinePlaceboTotal
Mean6.07 ± 1.396.14 ± 1.276.11 ± 1.33

5 further baseline measures are reported on the registry.

08

Study locations

7 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Fort Myers, Florida 33916, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Edison, New Jersey 08817, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Lake Jackson, Texas 77566, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Athens, 14561, Greece
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Heraklion, 71110, Greece
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Moscow, 119992, Russian Federation
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Gothenburg, 40014, Sweden
09

References and documents

Publications

  • Yue L, Wang J, Enomoto H, Fujikoshi S, Alev L, Cheng YY, Skljarevski V. The Clinical Relevance of Pain Severity Changes: Is There Any Difference Between Asian and Caucasian Patients With Osteoarthritis Pain? Pain Pract. 2020 Feb;20(2):129-137. doi: 10.1111/papr.12835. Epub 2019 Nov 20. PubMed 31505082 ↗
  • Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17. PubMed 24650448 ↗
  • Hochberg MC, Wohlreich M, Gaynor P, Hanna S, Risser R. Clinically relevant outcomes based on analysis of pooled data from 2 trials of duloxetine in patients with knee osteoarthritis. J Rheumatol. 2012 Feb;39(2):352-8. doi: 10.3899/jrheum.110307. Epub 2011 Dec 1. PubMed 22133624 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00433290
Lead sponsor
Eli Lilly and Company
First posted
Feb 9, 2007
Start date
Feb 2007
Primary completion
May 2008
Completion
May 2008
Results posted
Aug 24, 2009
Last update
Sep 2, 2009

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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