NCT00955513

Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain

A Randomized, Double-blind, Multi-center, Placebo-controlled, 3-treatment Arm, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).

Conditions

• Grade I/II Ankle Sprain

Interventions

Type	Name	Description
DRUG	diclofenac diethylamine gel 2.32%	diclofenac diethylamine gel 2.32% twice a day
DRUG	diclofenac diethylamine gel 2.32%	diclofenac diethylamine gel 2.32% three times a day
DRUG	Placebo	Placebo

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-08-10
• Last updated: 2012-04-20
• Results posted: 2011-01-26

Locations

5 sites across 1 country: Germany