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A Randomized, Double-blind, Multi-center, Vehicle-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Once or Twice Daily in Patients With Acute Ankle Sprain
This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.
Details
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 271 |
| Start date | 2007-11 |
| Completion | 2008-07 |
Conditions
- Ankle Sprain
Interventions
- Diclofenac diethylamine 2.32% gel
- Placebo
- Diclofenac diethylamine 2.32% gel / Placebo
Primary outcomes
- Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. — change from baseline (on day 1) to day 5
Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)
Countries
Germany