NCT01255423

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain

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 4 Times Daily in Subjects With Acute Ankle Sprain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.

Conditions

• Ankle Sprain

Interventions

Type	Name	Description
DRUG	Diclofenac sodium topical gel 1%	Diclofenac sodium topical gel 1%, 4 times daily
DRUG	Placebo	Placebo, 4 times daily

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-12-07
• Last updated: 2012-10-04
• Results posted: 2012-10-04

Locations

9 sites across 1 country: United States