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

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

Drug Information available for:

Diclofenac Diclofenac potassium Diclofenac sodium

U.S. FDA Resources

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

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Pain on movement on day 5 [ Time Frame: day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain on movement on days 3 and 8 [ Time Frame: days 3 and 8 ] [ Designated as safety issue: No ]
Pain at rest on days 3, 5, and 8 [ Time Frame: days 3, 5, and 8 ] [ Designated as safety issue: No ]
Pain relief on days 3, 5, and 8 [ Time Frame: days 3, 5, and 8 ] [ Designated as safety issue: No ]
Ankle joint function on days 3, 5, and 8 [ Time Frame: days 3, 5, and 8 ] [ Designated as safety issue: No ]
Global assessment of benefit on days 3, 5, and 8 [ Time Frame: days 3, 5, and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	270
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
1: Active Comparator	Drug: Diclofenac diethylamine 2.32% gel Diclofenac diethylamine 2.32% gel twice daily
2: Placebo Comparator	Drug: Placebo Vehicle 2 times daily
3: Active Comparator	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
	Dusseldorf, Germany, 40212
	Novartis Investigative Site
	Munchen, Germany, 80333
	Novartis Investigative Site
	Munchen, Germany, 80538
	Novartis Investigative Site
	Munchen, Germany, 80798
	Novartis Investigative Site
	Berlin, Germany, 10961
	Novartis Investigative Site
	Berlin, Germany, 12349
	Novartis Investigative Site
	Berlin, Germany, 14169
	Novartis Investigative Site
	Berlin, Germany, 14163
	Novartis Investigative Site
	Berlin, Germany, 10589
	Novartis Investigative Site
	Berlin, Germany, 12247
	Novartis Investigative Site
	Hamburg, Germany, 22143
	Novartis Investigative Site
	Hamburg, Germany, 20357
	Novartis Investigative Site
	Bad Nauheim, Germany, 61231
	Novartis Investigative Site
	Leipzig, Germany, 04109
	Novartis Investigative Site
	Eichstätt, Germany, 85072
	Novartis Investigative Site
	Bochum, Germany, 44789
	Novartis Investigative Site
	Meersburg, Germany, 88709
	Novartis Investigative Site
	Stockach, Germany, 78333
	Novartis Investigative Site
	Lambrecht/Pfalz, Germany, 67466
	Novartis Investigative Site
	Hammelburg, Germany, 97762
	Novartis Investigative Site
	Bad Bramstedt, Germany, 24576
	Novartis Investigative Site
	Kaufbeuren, Germany, 87600
	Novartis Investigative Site
	Bad Zwischenahn, Germany, 26160
	Novartis Investigative Site
	Dortmund, Germany, 44263
	Novartis Investigative Site
	Karlsruhe, Germany, 76133
	Novartis Investigative Site
	Munich, Germany, 80339
	Novartis Investigative Site
	Neustadt/Aisch, Germany, 91413
	Novartis Investigative Site
	Siegen, Germany, 57074
	Novartis Investigative Site
	Dresden, Germany, 01129

Sponsors and Collaborators

Novartis

Investigators


Principal Investigator:	Axel Baltzer	Unaffiliated

More Information

Responsible Party:	Novartis Consumer Health ( Novartis Consumer Health )
Study ID Numbers:	VOPO-PE-201
First Received:	December 13, 2007
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00573768
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices (BfArM)

Keywords provided by Novartis:

Ankle, sprain, diclofenac diethylamine

Study placed in the following topic categories:

Wounds and Injuries

Diclofenac

Disorders of Environmental Origin

Sprains and Strains

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2008

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