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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573768
First Posted: December 14, 2007
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
December 13, 2007
December 14, 2007
July 28, 2010
November 18, 2010
April 20, 2012
November 2007
December 2007   (Final data collection date for primary outcome measure)
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)
Pain on movement on day 5 [ Time Frame: day 5 ]
Complete list of historical versions of study NCT00573768 on ClinicalTrials.gov Archive Site
Not Provided
  • Pain on movement on days 3 and 8 [ Time Frame: days 3 and 8 ]
  • Pain at rest on days 3, 5, and 8 [ Time Frame: days 3, 5, and 8 ]
  • Pain relief on days 3, 5, and 8 [ Time Frame: days 3, 5, and 8 ]
  • Ankle joint function on days 3, 5, and 8 [ Time Frame: days 3, 5, and 8 ]
  • Global assessment of benefit on days 3, 5, and 8 [ Time Frame: days 3, 5, and 8 ]
Not Provided
Not Provided
 
Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain
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
This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Ankle Sprain
  • Drug: Diclofenac diethylamine 2.32% gel
    Diclofenac diethylamine 2.32% gel twice daily
  • Drug: Placebo
    Vehicle 2 times daily
  • Drug: Diclofenac diethylamine 2.32% gel / Placebo
    Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily
  • Active Comparator: 1
    Intervention: Drug: Diclofenac diethylamine 2.32% gel
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
  • Active Comparator: 3
    Intervention: Drug: Diclofenac diethylamine 2.32% gel / Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
271
July 2008
December 2007   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00573768
VOPO-PE-201
No
Not Provided
Not Provided
Novartis
Novartis
Not Provided
Principal Investigator: Axel Baltzer
Novartis
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP