Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Grade I/II Ankle Sprain
Intervention: diclofenac diethylamine gel 2.32% (Drug); diclofenac diethylamine gel 2.32% (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Novartis Overall contact:
Novartis Consumer Health SA Novartis Consumer Health SA, Phone: +41223635528
Summary
The main purpose of this trial is to compare the efficacy and safety of diclofenac
diethylamine 2. 32% gel applied twice (b. i.d) or three times a day (t. i.d.) with placebo in
the treatment of acute ankle sprains (distortions).
Clinical Details
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, 3-treatment Arm, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: Measure: Pain on Movement
Secondary outcome: Secondary Outcome Measure #1:
Measure:POM on VASSecondary Outcome Measure #2:
Measure: Pain at rest Secondary Outcome Measure #3:
Measure: Tenderness Secondary Outcome Measure #4:
Measure: Ankle Joint Function Secondary Outcome Measure #5:
Measure: Circumference measurement of swelling
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Acute sprain of the lateral ankle, Grade I-II .
Exclusion Criteria:
1. Any concurrent injury affecting the lower extremities that is painful at rest or on
movement, or could affect the mobilization of the patient.
2. Topical analgesic or anti-inflammatory treatment over the previous month in the area
to be treated.
Locations and Contacts
Novartis Consumer Health SA Novartis Consumer Health SA, Phone: +41223635528
Novartis Investigative Site, Cologne, Germany; Recruiting
Novartis Investigative Site, Gilching, Germany; Recruiting
Novartis Investigative Site, Grunwald, Germany; Recruiting
Novartis Investigative Site, Munchen, Germany; Recruiting
Novartis Investigative Site, Essen, Germany; Recruiting
Additional Information
Starting date: June 2009
Ending date: May 2010
Last updated: August 10, 2009
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