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

Ankle Sprain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573768
• Other study ID #: VOPO-PE-201
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2007
• Last updated: April 18, 2012
• Start date: November 2007
• Est. completion date: July 2008

Study information

• Verified date: October 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: July 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain

Intervention

Drug:
• Diclofenac diethylamine 2.32% gel
Diclofenac diethylamine 2.32% gel twice daily
• Placebo
Vehicle 2 times daily
• Diclofenac diethylamine 2.32% gel / Placebo
Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Bad Bramstedt
Germany	Novartis Investigative Site	Bad Nauheim
Germany	Novartis Investigative Site	Bad Zwischenahn
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dusseldorf
Germany	Novartis Investigative Site	Eichstätt
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hammelburg
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Kaufbeuren
Germany	Novartis Investigative Site	Lambrecht/Pfalz
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Meersburg
Germany	Novartis Investigative Site	Munchen
Germany	Novartis Investigative Site	Munchen
Germany	Novartis Investigative Site	Munchen
Germany	Novartis Investigative Site	Munich
Germany	Novartis Investigative Site	Neustadt/Aisch
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Stockach

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	change from baseline (on day 1) to day 5	No