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

Phase 3

Completed

• Conditions: Grade I/II Ankle Sprain
• Interventions: Drug: diclofenac diethylamine gel 2.32%; Drug: Placebo

• Registration Number: NCT00955513
• Lead Sponsor: Novartis

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-12-01
• Status Verified: 2011-01
• Results First Submitted QC: 2011-01-07
• Results First Posted: 2011-01-26
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

1. Acute sprain of the lateral ankle, Grade I-II .

Exclusion Criteria

1. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
2. Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diclofenac diethylamine gel 2.32% gel twice a day	diclofenac diethylamine gel 2.32%	drug
diclofenac diethylamine gel 2.32% gel three times a day	diclofenac diethylamine gel 2.32%	drug
placebo	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
Measure: Pain on Movement on Day 5 (Change From Baseline).	baseline and day 5	Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Munchen, Germany