NCT02087748

An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Efficacy and Safety of Voltaren Gel in Subjects With DOMS

A Randomized, Double-Blind, Within-Subject, Proof of Concept Study to Assess the Analgesic Efficacy and Safety of Voltaren Gel (1% Diclofenac Sodium) Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Lotus Clinical Research, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness.

Detailed description

The purpose of this randomized, double-blind, placebo controlled, within-subject study is to evaluate the efficacy of topical diclofenac sodium gel (DSG) 1% in reducing pain associated with delayed onset muscle soreness (DOMS). Following exercise, subjects reporting significant DOMS received topical DSG 1% applied to 1 leg and placebo applied to the other every 6 hours for 48 hours.

Conditions

• Pain
• Delayed Onset Muscle Soreness

Interventions

Type	Name	Description
DRUG	1% diclofenac sodium gel	Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours
DRUG	Placebo	Placebo gel 4gm applied topically Q6 hour for 48 hours

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2014-03-14
• Last updated: 2014-12-10
• Results posted: 2014-12-10

Locations

1 site across 1 country: United States