Overview

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

Status:
Completed
Trial end date:
2019-04-11
Target enrollment:
0
Participant gender:
All
Summary
Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Aponia Laboratories, Inc.
Treatments:
Ibuprofen
Criteria
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