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

NCT00955513 Phase 3 COMPLETED Results posted

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).

Details

Lead sponsor	Novartis
Phase	Phase 3
Status	COMPLETED
Enrolment	242
Start date	2009-07
Completion	2009-12

Conditions

• Grade I/II Ankle Sprain

Interventions

• diclofenac diethylamine gel 2.32%
• diclofenac diethylamine gel 2.32%
• Placebo

Primary outcomes

• 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.

Countries

Germany