Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00955513

Purpose

The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).

Condition	Intervention	Phase
Grade I/II Ankle Sprain	Drug: diclofenac diethylamine gel 2.32% Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	A Randomized, Double-blind, Multi-center, Placebo-controlled, 3-treatment Arm, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times 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:

Measure: Pain on Movement [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary Outcome Measure #1: Measure:POM on VAS [ Time Frame: Days 3 and 8 (+/-1), respectively ] [ Designated as safety issue: No ]
Secondary Outcome Measure #2: Measure: Pain at rest [ Time Frame: Days 3, 5 and 8 (+/-1) ] [ Designated as safety issue: No ]
Secondary Outcome Measure #3: Measure: Tenderness [ Time Frame: Days 3, 5 and 8 (+/-1) ] [ Designated as safety issue: No ]
Secondary Outcome Measure #4: Measure: Ankle Joint Function [ Time Frame: Days 3, 5 and 8 (+/-1) ] [ Designated as safety issue: No ]
Secondary Outcome Measure #5: Measure: Circumference measurement of swelling [ Time Frame: Days 3, 5 and 8 (+/-1) ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	July 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
diclofenac diethylamine gel 2.32% gel twice a day: Experimental drug	Drug: diclofenac diethylamine gel 2.32% diclofenac diethylamine gel 2.32% twice a day
diclofenac diethylamine gel 2.32% gel three times a day: Experimental drug	Drug: diclofenac diethylamine gel 2.32% diclofenac diethylamine gel 2.32% three times a day
placebo: Placebo Comparator placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Acute sprain of the lateral ankle, Grade I-II .

Exclusion Criteria:

Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955513

Locations

Germany
Novartis Investigative Site
Cologne, Germany
Novartis Investigative Site
Gilching, Germany
Novartis Investigative Site
Grunwald, Germany
Novartis Investigative Site
Munchen, Germany
Novartis Investigative Site
Essen, Germany

Sponsors and Collaborators

Novartis

More Information

No publications provided

Responsible Party:	Novartis Consumer Health SA ( Novartis Consumer Health SA )
Study ID Numbers:	VOPO-P-307
Study First Received:	August 7, 2009
Last Updated:	December 22, 2009
ClinicalTrials.gov Identifier:	NCT00955513 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices (BfArM)

Keywords provided by Novartis:

Ankle sprain
soft tissue injury

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Wounds and Injuries
Disorders of Environmental Origin
Diclofenac
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
Sprains and Strains

ClinicalTrials.gov processed this record on February 08, 2010