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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00955513
First received: August 7, 2009
Last updated: April 18, 2012
Last verified: January 2011
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Pain on Movement on Day 5 (Change From Baseline). [ Time Frame: baseline and day 5 ] [ Designated as safety issue: No ]
    Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.


Enrollment: 242
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
Experimental: diclofenac diethylamine gel 2.32% gel twice a day
drug
 Drug: diclofenac diethylamine gel 2.32%
diclofenac diethylamine gel 2.32% twice a day
Experimental: diclofenac diethylamine gel 2.32% gel three times a day
drug
 Drug: diclofenac diethylamine gel 2.32%
diclofenac diethylamine gel 2.32% three times a day
Placebo Comparator: placebo
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:

  1. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
  2. 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
Essen, Germany
Novartis Investigative Site
Gilching, Germany
Novartis Investigative Site
Grunwald, Germany
Novartis Investigative Site
Munchen, Germany
Sponsors and Collaborators
Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00955513     History of Changes
Other Study ID Numbers: VOPO-P-307
Study First Received: August 7, 2009
Results First Received: December 1, 2010
Last Updated: April 18, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)

Keywords provided by Novartis:
Ankle sprain
soft tissue injury

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 May 21, 2013