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Sponsored by: |
Novartis |
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00573768 |
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 II |
Drug Information available for: | Diclofenac Diclofenac potassium Diclofenac sodium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 270 |
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 |
1: Active Comparator |
Drug: Diclofenac diethylamine 2.32% gel
Diclofenac diethylamine 2.32% gel twice daily
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2: Placebo Comparator |
Drug: Placebo
Vehicle 2 times daily
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3: Active Comparator |
Drug: Diclofenac diethylamine 2.32% gel / Placebo
Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Germany | |||||
Novartis Investigative Site | |||||
Dusseldorf, Germany, 40212 | |||||
Novartis Investigative Site | |||||
Munchen, Germany, 80333 | |||||
Novartis Investigative Site | |||||
Munchen, Germany, 80538 | |||||
Novartis Investigative Site | |||||
Munchen, Germany, 80798 | |||||
Novartis Investigative Site | |||||
Berlin, Germany, 10961 | |||||
Novartis Investigative Site | |||||
Berlin, Germany, 12349 | |||||
Novartis Investigative Site | |||||
Berlin, Germany, 14169 | |||||
Novartis Investigative Site | |||||
Berlin, Germany, 14163 | |||||
Novartis Investigative Site | |||||
Berlin, Germany, 10589 | |||||
Novartis Investigative Site | |||||
Berlin, Germany, 12247 | |||||
Novartis Investigative Site | |||||
Hamburg, Germany, 22143 | |||||
Novartis Investigative Site | |||||
Hamburg, Germany, 20357 | |||||
Novartis Investigative Site | |||||
Bad Nauheim, Germany, 61231 | |||||
Novartis Investigative Site | |||||
Leipzig, Germany, 04109 | |||||
Novartis Investigative Site | |||||
Eichstätt, Germany, 85072 | |||||
Novartis Investigative Site | |||||
Bochum, Germany, 44789 | |||||
Novartis Investigative Site | |||||
Meersburg, Germany, 88709 | |||||
Novartis Investigative Site | |||||
Stockach, Germany, 78333 | |||||
Novartis Investigative Site | |||||
Lambrecht/Pfalz, Germany, 67466 | |||||
Novartis Investigative Site | |||||
Hammelburg, Germany, 97762 | |||||
Novartis Investigative Site | |||||
Bad Bramstedt, Germany, 24576 | |||||
Novartis Investigative Site | |||||
Kaufbeuren, Germany, 87600 | |||||
Novartis Investigative Site | |||||
Bad Zwischenahn, Germany, 26160 | |||||
Novartis Investigative Site | |||||
Dortmund, Germany, 44263 | |||||
Novartis Investigative Site | |||||
Karlsruhe, Germany, 76133 | |||||
Novartis Investigative Site | |||||
Munich, Germany, 80339 | |||||
Novartis Investigative Site | |||||
Neustadt/Aisch, Germany, 91413 | |||||
Novartis Investigative Site | |||||
Siegen, Germany, 57074 | |||||
Novartis Investigative Site | |||||
Dresden, Germany, 01129 |
Novartis |
Principal Investigator: | Axel Baltzer | Unaffiliated |
Responsible Party: | Novartis Consumer Health ( Novartis Consumer Health ) |
Study ID Numbers: | VOPO-PE-201 |
First Received: | December 13, 2007 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00573768 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices (BfArM) |
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