Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00573768

Purpose

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

Condition	Intervention	Phase
Ankle Sprain	Drug: Diclofenac diethylamine 2.32% gel Drug: Placebo Drug: Diclofenac diethylamine 2.32% gel / Placebo	Phase II

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

Resource links provided by NLM:

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)

Enrollment:	271
Study Start Date:	November 2007
Study Completion Date:	July 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: Diclofenac diethylamine 2.32% gel Diclofenac diethylamine 2.32% gel twice daily
Placebo Comparator: 2	Drug: Placebo Vehicle 2 times daily
Active Comparator: 3	Drug: Diclofenac diethylamine 2.32% gel / Placebo Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573768

Locations

Germany
Novartis Investigative Site
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, 10961
Novartis Investigative Site
Berlin, Germany, 14163
Novartis Investigative Site
Berlin, Germany, 12349
Novartis Investigative Site
Berlin, Germany, 10589
Novartis Investigative Site
Berlin, Germany, 12247
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, 22143
Novartis Investigative Site
Hamburg, Germany, 20357
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, 80798
Novartis Investigative Site
Munchen, Germany, 80333
Novartis Investigative Site
Munchen, Germany, 80538
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

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Axel Baltzer

More Information

No publications provided

Responsible Party:	Novartis Consumer Health
ClinicalTrials.gov Identifier:	NCT00573768 History of Changes
Other Study ID Numbers:	VOPO-PE-201
Study First Received:	December 13, 2007
Results First Received:	July 28, 2010
Last Updated:	October 21, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices (BfArM)

Keywords provided by Novartis:

Ankle, sprain, diclofenac diethylamine

Additional relevant MeSH terms:

Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012