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

April 18, 2012 updated by: Novartis

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 Overview

Study Type

Interventional

Enrollment (Actual)

271

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bad Bramstedt, Germany, 24576
        • Novartis Investigative Site
      • Bad Nauheim, Germany, 61231
        • Novartis Investigative Site
      • Bad Zwischenahn, Germany, 26160
        • Novartis Investigative Site
      • Berlin, Germany, 14169
        • Novartis Investigative Site
      • Berlin, Germany, 10589
        • Novartis Investigative Site
      • Berlin, Germany, 10961
        • Novartis Investigative Site
      • Berlin, Germany, 12247
        • Novartis Investigative Site
      • Berlin, Germany, 12349
        • Novartis Investigative Site
      • Berlin, Germany, 14163
        • Novartis Investigative Site
      • Bochum, Germany, 44789
        • Novartis Investigative Site
      • Dortmund, Germany, 44263
        • Novartis Investigative Site
      • Dresden, Germany, 01129
        • Novartis Investigative Site
      • Dusseldorf, Germany, 40212
        • Novartis Investigative Site
      • Eichstätt, Germany, 85072
        • Novartis Investigative Site
      • Hamburg, Germany, 20357
        • Novartis Investigative Site
      • Hamburg, Germany, 22143
        • Novartis Investigative Site
      • Hammelburg, Germany, 97762
        • Novartis Investigative Site
      • Karlsruhe, Germany, 76133
        • Novartis Investigative Site
      • Kaufbeuren, Germany, 87600
        • Novartis Investigative Site
      • Lambrecht/Pfalz, Germany, 67466
        • Novartis Investigative Site
      • Leipzig, Germany, 04109
        • Novartis Investigative Site
      • Meersburg, Germany, 88709
        • Novartis Investigative Site
      • Munchen, Germany, 80333
        • Novartis Investigative Site
      • Munchen, Germany, 80538
        • Novartis Investigative Site
      • Munchen, Germany, 80798
        • Novartis Investigative Site
      • Munich, Germany, 80339
        • Novartis Investigative Site
      • Neustadt/Aisch, Germany, 91413
        • Novartis Investigative Site
      • Siegen, Germany, 57074
        • Novartis Investigative Site
      • Stockach, Germany, 78333
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Vehicle 2 times daily
Active Comparator: 1
Diclofenac diethylamine 2.32% gel twice daily
Active Comparator: 3
Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.
Time Frame: 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)
change from baseline (on day 1) to day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Axel Baltzer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

December 13, 2007

First Submitted That Met QC Criteria

December 13, 2007

First Posted (Estimate)

December 14, 2007

Study Record Updates

Last Update Posted (Estimate)

April 20, 2012

Last Update Submitted That Met QC Criteria

April 18, 2012

Last Verified

October 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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