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 ]

Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= "No pain" and 100= "Extreme pain"


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 ]

Onset of perceptible pain relief.


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