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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary:

• Pain on movement on day 5 day 5 No

Secondary:

• Pain on movement on days 3 and 8 days 3 and 8 No
• Pain at rest on days 3, 5, and 8 days 3, 5, and 8 No
• Pain relief on days 3, 5, and 8 days 3, 5, and 8 No
• Ankle joint function on days 3, 5, and 8 days 3, 5, and 8 No
• Global assessment of benefit on days 3, 5, and 8 days 3, 5, and 8 No

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

Lead Sponsor: Novartis

Novartis Investigative Site

Dusseldorf  40212 Germany

Novartis Investigative Site

Munchen  80333 Germany

Novartis Investigative Site

Munchen  80538 Germany

Novartis Investigative Site

Munchen  80798 Germany

Novartis Investigative Site

Berlin  10961 Germany

Novartis Investigative Site

Berlin  12349 Germany

Novartis Investigative Site

Berlin  14169 Germany

Novartis Investigative Site

Berlin  14163 Germany

Novartis Investigative Site

Berlin  10589 Germany

Novartis Investigative Site

Berlin  12247 Germany

Novartis Investigative Site

Hamburg  22143 Germany

Novartis Investigative Site

Hamburg  20357 Germany

Novartis Investigative Site

Bad Nauheim  61231 Germany

Novartis Investigative Site

Leipzig  04109 Germany

Novartis Investigative Site

Dresden  01129 Germany

Novartis Investigative Site

Bochum  44789 Germany

Novartis Investigative Site

Meersburg  88709 Germany

Novartis Investigative Site

Stockach  78333 Germany

Novartis Investigative Site

Lambrecht/Pfalz  67466 Germany

Novartis Investigative Site

Hammelburg  97762 Germany

Novartis Investigative Site

Bad Bramstedt  24576 Germany

Novartis Investigative Site

Kaufbeuren  87600 Germany

Novartis Investigative Site

Bad Zwischenahn  26160 Germany

Novartis Investigative Site

Dortmund  44263 Germany

Novartis Investigative Site

Karlsruhe  76133 Germany

Novartis Investigative Site

Munich  80339 Germany

Novartis Investigative Site

Neustadt/Aisch  91413 Germany

Novartis Investigative Site

Siegen  57074 Germany

Novartis Investigative Site

Eichstätt  85072 Germany

Overall Clinical Trial Officials and Contacts

Axel Baltzer Principal Investigator Unaffiliated  

Overall Contact: Novartis Consumer Health SA Novartis Consumer Health SA : +41 22 363 3111 

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00573768

Study ID Number: VOPO-PE-201

ClinicalTrials.gov Identifier: NCT00573768

Health Authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)