- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00573768
Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain
April 18, 2012 updated by: Novartis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
271
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bad Bramstedt, Germany, 24576
- Novartis Investigative Site
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Bad Nauheim, Germany, 61231
- Novartis Investigative Site
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Bad Zwischenahn, Germany, 26160
- Novartis Investigative Site
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Berlin, Germany, 14169
- Novartis Investigative Site
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Berlin, Germany, 10589
- Novartis Investigative Site
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Berlin, Germany, 10961
- Novartis Investigative Site
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Berlin, Germany, 12247
- Novartis Investigative Site
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Berlin, Germany, 12349
- Novartis Investigative Site
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Berlin, Germany, 14163
- Novartis Investigative Site
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Bochum, Germany, 44789
- Novartis Investigative Site
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Dortmund, Germany, 44263
- Novartis Investigative Site
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Dresden, Germany, 01129
- Novartis Investigative Site
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Dusseldorf, Germany, 40212
- Novartis Investigative Site
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Eichstätt, Germany, 85072
- Novartis Investigative Site
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Hamburg, Germany, 20357
- Novartis Investigative Site
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Hamburg, Germany, 22143
- Novartis Investigative Site
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Hammelburg, Germany, 97762
- Novartis Investigative Site
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Karlsruhe, Germany, 76133
- Novartis Investigative Site
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Kaufbeuren, Germany, 87600
- Novartis Investigative Site
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Lambrecht/Pfalz, Germany, 67466
- Novartis Investigative Site
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Leipzig, Germany, 04109
- Novartis Investigative Site
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Meersburg, Germany, 88709
- Novartis Investigative Site
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Munchen, Germany, 80333
- Novartis Investigative Site
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Munchen, Germany, 80538
- Novartis Investigative Site
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Munchen, Germany, 80798
- Novartis Investigative Site
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Munich, Germany, 80339
- Novartis Investigative Site
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Neustadt/Aisch, Germany, 91413
- Novartis Investigative Site
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Siegen, Germany, 57074
- Novartis Investigative Site
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Stockach, Germany, 78333
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
Vehicle 2 times daily
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Active Comparator: 1
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Diclofenac diethylamine 2.32% gel twice daily
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Active Comparator: 3
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Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
change from baseline (on day 1) to day 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Axel Baltzer
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
December 13, 2007
First Submitted That Met QC Criteria
December 13, 2007
First Posted (Estimate)
December 14, 2007
Study Record Updates
Last Update Posted (Estimate)
April 20, 2012
Last Update Submitted That Met QC Criteria
April 18, 2012
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Leg Injuries
- Sprains and Strains
- Ankle Injuries
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Diclofenac
Other Study ID Numbers
- VOPO-PE-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankle Sprain
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Decathlon SEEFOR, FranceTerminatedAnkle Sprain 1St Degree | Ankle Sprain 2Nd Degree | Ankle Sprain 3Rd DegreeFrance
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National Defense Medical Center, TaiwanTri-Service General HospitalRecruitingAnkle Sprain 2Nd Degree | Ankle Sprain 3Rd DegreeTaiwan
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Instituto Mexicano del Seguro SocialCompletedAnkle Sprain | Ankle Sprain 1St Degree | Ankle Sprain 2Nd DegreeMexico
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Université Catholique de LouvainCompletedAnkle Sprain 1St Degree | Ankle Sprain 2Nd DegreeBelgium
-
Vanderbilt University Medical CenterRecruitingMusculoskeletal Injury | Ankle Sprain 1St Degree | Ankle Sprain 2Nd DegreeUnited States
-
University of VirginiaNational Athletic Training Association Research & Education FoundationUnknownLateral Ankle SprainUnited States
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Hospital Universitario Infanta LeonorCompletedMild Ankle SprainSpain
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University Hospital, GrenobleCompleted
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Université Catholique de LouvainUZ Leuven, campus Pellenberg (Belgium)RecruitingChronic Ankle Instability | Lateral Ankle SprainBelgium
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-
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