Study of SST-0225 Topical Ibuprofen Cream in the Treatment of Delayed Onset Muscle Soreness (DOMS) — DOMS  

Delayed Onset Muscle Soreness, DOMS Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy, and Safety of SST-0225, a Topical Ibuprofen Cream, in the Treatment of Delayed Onset Muscle Soreness (DOMS)

Status Completed

Clinical Trial Summary

This is a Phase 3, prospective, randomized, dual-center, double-blind, placebo-controlled, parallel-group study designed to determine the efficacy and safety of SST-0225 (5.4 grams, applied up to 6 times in 24 hours, over a 48-hour dosing period) for the treatment of pain associated with DOMS.

Clinical Trial Description

This is a Phase 3, prospective, randomized, multicenter, double blind, placebo controlled, parallel group study designed to determine the efficacy and safety of SST-0225 for the treatment of pain associated with DOMS. Healthy volunteers will be recruited to undergo an exercise regimen designed to induce DOMS in the elbow flexor of the non-dominant arm. Subjects who are eligible following the exercise regimen will be randomized to receive treatment with SST-0225 or placebo for a 48 hour period. Subjects will be housed in the clinic for the first 24 hours of dosing and sent home for the second 24 hour dosing period. Arm pain/soreness will be assessed throughout the study using an 11-point (0-10) Numeric Rating Scale (NRS).

Approximately 150 subjects will be randomized in a 1:1 ratio to SST-0225 or placebo at up to three study centers in the US. Subject participation will be between 12 and 26 days depending on the length of the initial screening period. Once a subject is randomized the duration of participation will be 10 days. The expected duration of the study is approximately six months depending on enrollment. The sample size may be increased to a maximum of 250 based on the results of the planned interim analysis described in Section 15.2 of the protocol. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delayed Onset Muscle Soreness, DOMS
• Myalgia

• NCT number: NCT02597634
• Study type: Interventional
• Source: Strategic Science & Technologies, LLC
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Completion date: October 2016