NCT01272934

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (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 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

• Acute Ankle Sprain

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium	Topical gel 1%-4 times daily
OTHER	Placebo	Topical gel-4 times daily

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-01-10
• Last updated: 2013-01-24
• Results posted: 2013-01-15

Locations

6 sites across 1 country: Germany