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

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).

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Key information

Conditions

Grade I/II Ankle Sprain Ankle Injuries Leg Injuries Soft Tissue Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

diclofenac diethylamine gel 2.32%

Drug

diclofenac diethylamine gel 2.32% twice a day

Placebo

Drug

Placebo

Primary outcomes

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

Time frame: baseline and day 5

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Aug 10, 2009
Registry last updated: Apr 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed