Sprain Clinical Trial
Official title:
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Ketotransdelâ„¢ (Ketoprofen Topical Cream 10%) in the Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury.
Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment of acute musculoskeletal pain.
The primary objective of this study is to determine the efficacy and safety of ketoprofen 10% cream compared to placebo as a three-times-per-day topical application in improving the patient assessment of pain when used to treat mild to moderate acute soft tissue injury of the upper and lower extremities over a 7-day period. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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