Clinical Trial: Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects Wi
Brief Summary: The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Pain on Movement [ Time Frame: VAS Score at 24 hours ]
Original Primary Outcome: Pain on Movement [ Time Frame: 24 hours ]
Current Secondary Outcome: Onset of Pain Relief [ Time Frame: From randomization to end of day 1 ]
Original Secondary Outcome: Onset of Pain Relief [ Time Frame: On day 1 ]
Information By: Novartis
Dates:
Date Received: January 7, 2011
Date Started: January 2011
Date Completion:
Last Updated: December 6, 2012
Last Verified: December 2012