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A Randomized, Multicenter, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee
The primary objective of the study is to assess analgesic efficacy of Impracor (Ketoprofen 10% Cream) compared to placebo for acute pain associated with OA flare of the knee.
Details
| Lead sponsor | Imprimis Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | WITHDRAWN |
| Start date | 2013-08 |
Conditions
- Acute Pain (Flare) Associated With Osteoarthritis (OA) of the Knee
Interventions
- Ketoprofen 10% Cream
- Placebo
Primary outcomes
- The primary endpoint will be measured by changes in WOMAC pain subscale scores calculated by comparing baseline WOMAC pain subscale scores on Day 1 to the average WOMAC Pain Subscale scores on Day 4, 6, and 8. — Day 4, 6 and 8