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

Condition(s) targeted: Ankle Sprain

Intervention: Diclofenac diethylamine 2.32% gel (Drug); Placebo (Drug); Diclofenac diethylamine 2.32% gel / Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Axel Baltzer, Principal Investigator, Affiliation: Unaffiliated

Overall contact:
Novartis Consumer Health SA Novartis Consumer Health SA, Phone: : +41 22 363 3111

This study will evaluate the efficacy of diclofenac diethylamine 2. 32% gel in the treatment of acute ankle sprain.

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

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

Primary outcome: Pain on movement on day 5

Secondary outcome:

Pain on movement on days 3 and 8

Pain at rest on days 3, 5, and 8

Pain relief on days 3, 5, and 8

Ankle joint function on days 3, 5, and 8

Global assessment of benefit on days 3, 5, and 8

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Novartis Consumer Health SA Novartis Consumer Health SA, Phone: : +41 22 363 3111

Novartis Investigative Site, Dusseldorf 40212, Germany; Recruiting

Novartis Investigative Site, Munchen 80333, Germany; Recruiting

Novartis Investigative Site, Munchen 80538, Germany; Terminated

Novartis Investigative Site, Munchen 80798, Germany; Recruiting

Novartis Investigative Site, Berlin 10961, Germany; Recruiting

Novartis Investigative Site, Berlin 12349, Germany; Recruiting

Novartis Investigative Site, Berlin 14169, Germany; Recruiting

Novartis Investigative Site, Berlin 14163, Germany; Recruiting

Novartis Investigative Site, Berlin 10589, Germany; Recruiting

Novartis Investigative Site, Berlin 12247, Germany; Terminated

Novartis Investigative Site, Hamburg 22143, Germany; Recruiting

Novartis Investigative Site, Hamburg 20357, Germany; Recruiting

Novartis Investigative Site, Bad Nauheim 61231, Germany; Recruiting

Novartis Investigative Site, Leipzig 04109, Germany; Terminated

Novartis Investigative Site, Dresden 01129, Germany; Terminated

Novartis Investigative Site, Bochum 44789, Germany; Recruiting

Novartis Investigative Site, Meersburg 88709, Germany; Recruiting

Novartis Investigative Site, Stockach 78333, Germany; Recruiting

Novartis Investigative Site, Lambrecht/Pfalz 67466, Germany; Recruiting

Novartis Investigative Site, Hammelburg 97762, Germany; Recruiting

Novartis Investigative Site, Bad Bramstedt 24576, Germany; Recruiting

Novartis Investigative Site, Kaufbeuren 87600, Germany; Recruiting

Novartis Investigative Site, Bad Zwischenahn 26160, Germany; Recruiting

Novartis Investigative Site, Dortmund 44263, Germany; Recruiting

Novartis Investigative Site, Karlsruhe 76133, Germany; Recruiting

Novartis Investigative Site, Munich 80339, Germany; Recruiting

Novartis Investigative Site, Neustadt/Aisch 91413, Germany; Recruiting

Novartis Investigative Site, Siegen 57074, Germany; Recruiting

Novartis Investigative Site, Eichstätt 85072, Germany; Recruiting

Starting date: November 2007
Ending date: June 2008
Last updated: May 27, 2008