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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:
ClinicalTrials.gov Identifier:
NCT00955513
First Posted: August 10, 2009
Last Update Posted: April 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  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: Triple (Participant, 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:


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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00955513     History of Changes
Other Study ID Numbers: VOPO-P-307
First Submitted: August 7, 2009
First Posted: August 10, 2009
Results First Submitted: December 1, 2010
Results First Posted: January 26, 2011
Last Update Posted: April 20, 2012
Last Verified: January 2011

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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action