Phase 3
N=231
Duloxetine Versus Placebo for Osteoarthritis Knee Pain
Osteoarthritis Knee Pain
Bottom Line
View on ClinicalTrials.gov: NCT00408421 ↗Enrolled (actual)
231
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary — -0.36; -0.84; -0.95; -1.54 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Duloxetine (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary |
-0.36; -0.84; -0.95; -1.54; -1.23; -1.85 | <0.001 sig |
| SECONDARY Patient Global Impression of Improvement at 13 Week Endpoint |
2.91; 2.38 | 0.001 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale |
10.95; 10.98; -3.19; -4.62 | 0.003 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale |
4.80; 4.74; -1.37; -1.97 | 0.004 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale |
38.50; 39.10; -11.58; -16.46 | 0.001 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score |
53.36; 53.72; -15.93; -22.19 | 0.004 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score |
7.54; 7.45; -2.01; -2.81 | 0.005 sig |
| SECONDARY Weekly Change From Baseline in the 24-Hour Worst Pain Score |
-0.31; -0.82; -0.92; -1.57; -1.20; -1.99 | <0.001 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase |
5.96; 6.22; -2.46; -3.44 | 0.039 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity |
2.62; 2.71; -0.21; -0.70 | 0.001 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score |
7.64; 7.60; -2.15; -3.17 | <0.001 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score |
5.09; 5.07; -1.60; -2.30 | 0.004 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score |
6.25; 6.19; -1.77; -2.71 | <0.001 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score |
6.02; 5.77; -2.26; -2.94 | 0.003 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity |
5.55; 5.50; -1.97; -2.63 | 0.019 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood |
4.22; 4.06; -1.69; -1.95 | 0.164 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability |
6.00; 5.72; -2.36; -2.80 | 0.049 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work |
5.80; 5.63; -2.25; -2.66 | 0.093 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People |
3.27; 3.05; -1.30; -1.43 | 0.287 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep |
4.16; 4.23; -1.57; -2.18 | 0.033 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life |
4.04; 4.42; -1.39; -2.38 | 0.015 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference |
4.72; 4.66; -1.79; -2.29 | 0.029 sig |
| SECONDARY Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings |
53; 64 | 0.033 sig |
| SECONDARY Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase |
26; 32 | 0.075 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary |
56.58; 56.43; -1.03; 1.06 | 0.088 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary |
30.57; 31.56; 6.36; 7.71 | 0.080 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score |
0.70; 0.68; 0.07; 0.14 | <0.001 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score |
5.64; 5.49; -0.97; -1.26 | 0.641 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale |
5.36; 4.59; -0.93; -1.15 | 0.193 |
| SECONDARY Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase |
76.97; 78.59; -1.94; 2.08 | 0.003 sig |
| SECONDARY Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid |
314.57; 322.77; 6.82; -5.00 | 0.026 sig |
| SECONDARY Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate |
70.07; 69.75; 1.26; 2.02 | 0.459 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic |
76.44; 77.00; -0.38; 0.95 | 0.326 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic |
129.42; 128.27; -2.29; 1.04 | 0.069 |
| SECONDARY Change From Baseline to 13 Week Endpoint in Vital Signs - Weight |
85.56; 85.39; -0.33; -0.79 | 0.107 |
Summary
The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients with osteoarthritis knee pain.
Exclusion Criteria
- 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.
- Acute liver injury (such as hepatitis) or severe cirrhosis.
- Previous exposure to duloxetine.
- Body Mass Index (BMI) over 40.
- Major depressive disorder.
- Daily use of narcotics.
Data sourced from ClinicalTrials.gov (NCT00408421). 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.