Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain

Novartis242 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

242

Conditions

Grade I/II Ankle Sprain

Interventions

diclofenac diethylamine gel 2.32%DRUG

diclofenac diethylamine gel 2.32% twice a day

diclofenac diethylamine gel 2.32%DRUG

diclofenac diethylamine gel 2.32% three times a day

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Novartis Investigative Site

Cologne, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Gilching, Germany

Novartis Investigative Site

Grünwald, Germany

Novartis Investigative Site

Outcomes

Primary Outcomes

Measure: Pain on Movement on Day 5 (Change From Baseline).

Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.

Time frame: baseline and day 5

Data from ClinicalTrials.gov

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