NCT03852459

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

A Randomized, Double-Blind,Vehicle-Controlled Study to Determine the Efficacy and Safety of AP0302 in the Treatment of Delayed Onset Muscle Soreness (DOMS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Aponia Laboratories, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Pain, Acute

Interventions

Type	Name	Description
DRUG	S-Ibuprofen	Topical Gel 5%
DRUG	Vehicle	Vehicle Gel

Timeline

• Start date: 2018-01-12
• Primary completion: 2019-04-04
• Completion: 2019-04-11
• First posted: 2019-02-25
• Last updated: 2022-01-25
• Results posted: 2022-01-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study