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: 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
Inclusion Criteria
- Acute sprain of the lateral ankle, Grade I-II .
Exclusion Criteria
- Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Munchen, Germany