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

Phase 2

Completed

• Conditions: Ankle Sprain
• Interventions: Drug: Diclofenac diethylamine 2.32% gel; Drug: Placebo; Drug: Diclofenac diethylamine 2.32% gel / Placebo

• Registration Number: NCT00573768
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2007-12
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-14
• Study Completion: 2008-07
• Results First Submitted: 2010-07-28
• Status Verified: 2010-10
• Results First Submitted QC: 2010-10-21
• Results First Posted: 2010-11-18
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Diclofenac diethylamine 2.32% gel	-
2	Placebo	-
3	Diclofenac diethylamine 2.32% gel / Placebo	-

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Stockach, Germany