Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

Phase 2CompletedNCT00573768

Novartis271 enrolled

Overview

This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

271

Conditions

Ankle Sprain

Interventions

Diclofenac diethylamine 2.32% gelDRUG

Diclofenac diethylamine 2.32% gel twice daily

PlaceboDRUG

Vehicle 2 times daily

Diclofenac diethylamine 2.32% gel / PlaceboDRUG

Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Acute sprain of the ankle * Injury within past 48 hours. Exclusion Criteria: * Pain medication taken since the injury * Pain or instability in the same ankle due to previous ankle sprain or any other trauma. * Ankle sprain due to a known disease affecting the ligaments Other protocol-defined inclusion/exclusion criteria may apply

Locations (29)

Novartis Investigative Site

Bad Bramstedt, Germany

Outcomes

Primary Outcomes

Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.

Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)

Time frame: change from baseline (on day 1) to day 5

Data from ClinicalTrials.gov

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