Status:
COMPLETED
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
Lead Sponsor:
Novartis
Conditions:
Muscle Soreness
Eligibility:
All Genders
18-35 years
Phase:
PHASE3
Brief Summary
This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT02271854
Start Date
October 1 2014
End Date
December 1 2014
Last Update
April 5 2016
Active Locations (1)
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1
Lotus Clinical Research, 100 W California Blvd,
Pasadena, California, United States, 91105