Phase 3
Completed N=256
Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain
Osteoarthritis Knee Pain
Source: ClinicalTrials.gov NCT00433290 ↗
Enrolled (actual)
256
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Change in Brief Pain Inventory (BPI) 24-hour Average Rating — -1.80; -1.12; -2.47; -1.41 units on a scale — p=<0.001
Summary
The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Brief Pain Inventory (BPI) 24-hour Average Rating |
-1.80; -1.12; -2.47; -1.41; -2.72; -1.88 | <0.001 sig |
| SECONDARY Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I) |
2.85; 3.09 | 0.164 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale |
35.05; 36.82; -13.78; -10.75 | 0.016 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale |
10.24; 10.35; -4.27; -3.49 | 0.068 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale |
4.27; 4.50; -1.63; -1.36 | 0.064 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores |
6.05; 6.08; -2.39; -1.78; 7.58; 7.53 | 0.008 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S) |
-0.63; -0.32 | 0.009 sig |
| SECONDARY Number of Participants Who Responded to Treatment at 13 Week Endpoint |
79; 56 | <0.001 sig |
| SECONDARY 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 |
55.86; 54.47; 0.35; 1.10; 30.59; 28.70 | 0.897 |
| SECONDARY Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) |
0.68; 0.66; 0.09; 0.08 | 0.209 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II) |
4.29; 5.35; -0.82; -1.25 | 0.871 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) |
4.26; 4.16; -1.11; -0.69 | 0.138 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score |
7.49; 7.50; -2.74; -1.94 | 0.003 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score |
4.70; 4.63; -1.95; -1.24 | 0.015 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score |
6.09; 6.16; -2.54; -1.78 | <0.001 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score |
5.45; 5.36; -2.57; -1.80 | 0.007 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity |
4.70; 5.17; -2.26; -1.92 | 0.050 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood |
3.35; 3.60; -1.59; -1.72 | 0.913 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability |
5.41; 5.54; -2.63; -2.07 | 0.066 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work |
4.77; 4.88; -2.43; -1.56 | 0.001 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People |
2.36; 2.37; -1.16; -0.89 | 0.260 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep |
3.66; 4.02; -1.91; -1.91 | 0.489 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life |
3.10; 3.29; -1.53; -1.23 | 0.131 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference |
3.91; 4.13; -1.93; -1.62 | 0.082 |
| SECONDARY Adverse Events Reported as Reason for Discontinuation |
5; 0; 1; 2; 2; 0 | — |
| SECONDARY Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes |
77.33; 75.90; 2.38; -3.43; 22.61; 24.23 | <0.001 sig |
| SECONDARY Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride |
104.38; 104.18; -0.83; -0.08 | 0.042 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate |
68.74; 69.73; 2.55; 0.06 | 0.005 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure |
132.20; 131.42; -1.03; 0.89; 79.73; 79.83 | 0.285 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Vital Signs - Weight |
81.01; 80.49; -0.65; 0.47 | <0.001 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders |
5.30; -0.76 | 0.040 sig |
| SECONDARY Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint |
9 | — |
| SECONDARY Adverse Events Reported as Reason for Discontinuation in Nonresponders |
1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients with osteoarthritis knee pain.
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.
Data sourced from ClinicalTrials.gov (NCT00433290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.