Status:
COMPLETED
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Ankle Sprain or Strain
Lead Sponsor:
APR Applied Pharma Research s.a.
Conditions:
Sprain
Strain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.
Detailed Description
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with Grade 1 or Grade 2 ankle sprains or strains. Eligible patients will be randomized (in a 1:1 r...
Eligibility Criteria
Inclusion
- Males or females 18 years of age or older
- Diagnosis of Grade I or Grade II ankle sprain or strain
- Meet pain entry criteria
- Willing to discontinue use of any pain medication not provided as part of the study
Exclusion
- Have a Grade 3 sprain or Grade 3 strain, bilateral sprain or strain, or concomitant fracture or wound at the site of the sprain or strain.
- Have received corticosteroids in the 30 days preceding screening
- Have a history or physical examination finding that is incompatible with safe participation in the study
- Have a history or physical examination finding that is incompatible with study product use
- Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
- Are taking medications that may significantly affect renal function
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00351104
Start Date
June 1 2006
End Date
March 1 2007
Last Update
February 19 2020
Active Locations (1)
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1
PPD
Austin, Texas, United States, 78704