Phase II Study of AP0302 5% Versus a Vehicle Comparator
Phase 2
Completed
- Conditions
- PainDelayed Onset Muscle Soreness
- Interventions
- Drug: S-Ibuprofen Topical Gel 5%Drug: Vehicle Topical Gel
- Registration Number
- NCT02324985
- Lead Sponsor
- Aponia Laboratories, Inc.
- Brief Summary
This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.
- Detailed Description
The purpose of this 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
Inclusion Criteria
- no clinically significant medical conditions
- BMI between 18-30
- negative drug, alcohol, pregnancy screens
- other protocol-defined inclusion criteria may apply
Exclusion Criteria
- no upper extremity workout in last 6 months
- no job requiring heavy lifting
- history of muscle disorders
- allergy or intolerance to study drug
- history of recent pain medication use
- other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Arm S-Ibuprofen Topical Gel 5% S-Ibuprofen Topical Gel 5% Placebo Arm Vehicle Topical Gel Vehicle Topical Gel
- Primary Outcome Measures
Name Time Method Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement 0-24 hours SPID 24
- Secondary Outcome Measures
Name Time Method Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement 0-48 hours SPID 48movement
Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest 0-48 hours SPID 48rest
Trial Locations
- Locations (1)
Lotus Clinical Research, LLC
🇺🇸Pasadena, California, United States