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Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

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ClinicalTrials.gov Identifier: NCT00573768
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : November 18, 2010
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

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

Condition or disease Intervention/treatment Phase
Ankle Sprain Drug: Diclofenac diethylamine 2.32% gel Drug: Placebo Drug: Diclofenac diethylamine 2.32% gel / Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


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): 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, 10589
Novartis Investigative Site
Berlin, Germany, 10961
Novartis Investigative Site
Berlin, Germany, 12247
Novartis Investigative Site
Berlin, Germany, 12349
Novartis Investigative Site
Berlin, Germany, 14163
Novartis Investigative Site
Berlin, Germany, 14169
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, 20357
Novartis Investigative Site
Hamburg, Germany, 22143
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, 80333
Novartis Investigative Site
Munchen, Germany, 80538
Novartis Investigative Site
Munchen, Germany, 80798
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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00573768     History of Changes
Other Study ID Numbers: VOPO-PE-201
First Posted: December 14, 2007    Key Record Dates
Results First Posted: November 18, 2010
Last Update Posted: April 20, 2012
Last Verified: October 2010

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