Status:
COMPLETED
Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS
Lead Sponsor:
Aponia Laboratories, Inc.
Conditions:
Pain, Acute
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%
Detailed Description
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).
Eligibility Criteria
Inclusion
- history of pain/soreness after exercise
- BMI between 18-30
- negative drug, alcohol, pregnancy screens
- other protocol-defined inclusion criteria may apply
Exclusion
- 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
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2019
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT03852459
Start Date
January 12 2018
End Date
April 11 2019
Last Update
January 25 2022
Active Locations (1)
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1
JBR Clinical Research
Salt Lake City, Utah, United States, 84107