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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Diclofenac

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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