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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00573768
First received: December 13, 2007
Last updated: April 18, 2012
Last verified: October 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)


Enrollment: 271
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
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

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 12349
Novartis Investigative Site
Berlin, Germany, 14169
Novartis Investigative Site
Berlin, Germany, 14163
Novartis Investigative Site
Berlin, Germany, 12247
Novartis Investigative Site
Berlin, Germany, 10961
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, 22143
Novartis Investigative Site
Hamburg, Germany, 20357
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, 80538
Novartis Investigative Site
Munchen, Germany, 80798
Novartis Investigative Site
Munchen, Germany, 80333
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
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00573768     History of Changes
Other Study ID Numbers: VOPO-PE-201
Study First Received: December 13, 2007
Results First Received: July 28, 2010
Last Updated: April 18, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)

Keywords provided by Novartis:
Ankle, sprain, diclofenac diethylamine

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries
Diclofenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014