NCT02324985

Phase II Study of AP0302 5% Versus a Vehicle Comparator

Phase II Study of the Effects of AP0302 5% (S-Ibuprofen Topical Gel 5%) Versus the Vehicle Control on Delayed Onset Muscle Soreness of the Elbow Flexors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Aponia Laboratories, Inc. · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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).

Conditions

• Pain
• Delayed Onset Muscle Soreness

Interventions

Type	Name	Description
DRUG	S-Ibuprofen Topical Gel 5%	S-Ibuprofen Topical Gel 5% applied every 6 hours
DRUG	Vehicle Topical Gel	Vehicle Topical Gel applied every 6 hours

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-07-01
• Completion: 2016-06-01
• First posted: 2014-12-24
• Last updated: 2019-02-25

Locations

1 site across 1 country: United States