Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 2/27/2019 |
Start Date: | January 12, 2018 |
End Date: | June 15, 2019 |
Contact: | K Corroon |
Email: | kcorroon@aponialabs.com |
Phone: | 917-574-5335 |
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%
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).
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
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