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

Completed · Phase 3 · Has a placebo group

Conditions studied: Muscle Soreness

In brief

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

Key facts

Study ID

NCT02271854

Run by

Novartis

People needed

102

Starts

2014-10-01

Expected to finish

2014-12-01

Last updated by the study team

2016-04-05

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged 18-35 years
• Not engaged in regular lower extremity fitness activities in the past 6 months prior to screening
• Willing to refrain from use of ice, heat and massage during the study
• DOMS score ≥4 Pain at Rest (PAR) and a DOMS score ≥5 Pain on Walking (POW), with moderate or severe on categorical scale

You may not qualify if…

• Pain medication \& corticosteroids prior to randomization
• Topical analgesic or anti-inflammatory treatment over the previous month
• Body mass index of >32 kg/m2
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Lotus Clinical Research, 100 W California Blvd, — Pasadena, California, United States

Full record on ClinicalTrials.gov

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