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

NCT02087748 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-12-10

Study results available
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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.

Conditions

  • Pain
  • Delayed Onset Muscle Soreness

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Neil Singla, MD · Lotus Clinical Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-04-30
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02087748 on ClinicalTrials.gov