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
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Diclofenac

Criteria

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.