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A Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness

NCT02271854 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2016-04-05

Study results available
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Summary

This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS

Conditions

  • Muscle Soreness

Interventions

DRUG

Diclofenac sodium gel 1%

Diclofenac sodium gel 1% four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).

DRUG

Placebo

Placebo gel four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02271854 on ClinicalTrials.gov