Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS

A Randomized, Double-Blind,Vehicle-Controlled Study to Determine the Efficacy and Safety of AP0302 in the Treatment of Delayed Onset Muscle Soreness (DOMS)

Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%

The purpose of this randomized, double-blind study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).

Inclusion Criteria:

• history of pain/soreness after exercise
• BMI between 18-30
• negative drug, alcohol, pregnancy screens
• other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• upper extremity workout in last 3 months
• job or hobby requiring heavy lifting
• history of muscle disorders
• allergy or intolerance to NSAID or study drug
• history of recent pain medication use
• other protocol-defined exclusion criteria may apply