Phase 3
N=524
A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis
Osteoarthritis Knee Pain
Bottom Line
View on ClinicalTrials.gov: NCT01018680 ↗Enrolled (actual)
524
Serious AEs
1.5%
Results posted
Oct 2012
Primary outcome: Primary: Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks — -1.55; -2.46 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
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks |
-1.55; -2.46 | <0.001 sig |
| SECONDARY Patient Global Impression of Improvement (PGI-I) at 8 Weeks |
2.93; 2.33 | <0.001 sig |
| SECONDARY Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks |
-10.25; -15.09; -3.13; -4.41; -1.45; -1.88 | <0.001 sig |
| SECONDARY Change From Baseline in the Weekly Mean of the 24-Hour Night Pain and Worst Pain Scores at 8 Weeks |
-1.46; -2.26; -1.58; -2.61 | <0.001 sig |
| SECONDARY Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) Scores at 8 Weeks |
-1.87; -2.94; -1.44; -2.14; -1.78; -2.73 | <0.001 sig |
| SECONDARY Change From Baseline in the Clinical Global Impression of Severity (CGI-S) at 8 Weeks |
-0.80; -1.16 | <0.001 sig |
| SECONDARY Change From Baseline in the Patient Global Assessment of Illness (PGAI) at 8 Weeks |
-1.77; -2.95 | <0.001 sig |
| SECONDARY Change From Baseline in the Profile of Mood States-Brief Form (BPOMS) Total and Subscale Scores at 8 Weeks |
-4.15; -4.98; -0.90; -1.17; -0.51; -0.85 | 0.449 |
| SECONDARY Percentage of Participants Using Acetaminophen Weekly During the 10-Week Treatment Period |
26; 22 | 0.083 |
| SECONDARY Percentage of Responders as Assessed by the Osteoarthritis Research Society International (OARSI) Response Criteria up to 8 Weeks |
48.3; 69.6 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved a 30 Percent or 50 Percent Reduction in the Weekly Mean of the 24-Hour Average Pain Score up to 8 Weeks |
33.7; 53.7; 16.1; 35.5 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved a 30 Percent or 50 Percent Reduction in the Brief Pain Inventory-Severity (BPI-S) Average Pain Score up to 8 Weeks |
34.0; 58.1; 21.1; 45.7 | <0.001 sig |
| SECONDARY Percentage of Participants Who Discontinued Due to an Adverse Event During the 10-Week Treatment Period |
8.8; 15.2 | 0.031 sig |
Summary
The study will test the hypothesis that, in patients with knee pain due to osteoarthritis (OA) who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) but still have significant knee pain, duloxetine 60 to 120 milligrams (mg) daily for 10 weeks will provide additional reduction in pain.
Eligibility Criteria
Inclusion Criteria
- Present with knee pain due to osteoarthritis (OA) based on OA clinical and radiographic diagnostic criteria.
- Knee Pain for > 14 days of each month for the 3 months directly preceding study entry.
- Taking nonsteroidal anti-inflammatory drugs (NSAIDs) for knee pain due to OA on most days in the 3 months immediately preceding study entry.
Exclusion Criteria
- History of intolerance or nonresponsiveness to an adequate trial of duloxetine used for any indication, in the opinion of the investigator.
- Previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
- Have major depressive disorder (MDD) as determined using depression module of the Mini International Neuropsychiatric Interview (MINI).
- Judged clinically by the investigator to be at suicidal risk by examination or using the Columbia Suicide Severity Rating Scale (C-SSRS).
- History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
- Positive urine drug screen for any substance of abuse or excluded medication.
- Opioid dependent in the opinion of the investigator, taking opioids more than 3 days a week, or unwilling to discontinue opioids during the study period.
- Known hypersensitivity to duloxetine or its inactive ingredients.
- History of intolerance or hypersensitivity to NSAIDS, Cyclooxygenase (COX-2) inhibitors, or proton pump inhibitors.
- History of peptic ulcer disease, bleeding disorder, gastrointestinal bleeding, or any abnormal bleeding.
- Baseline hemoglobin measurement of 40.
Data sourced from ClinicalTrials.gov (NCT01018680). 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.