Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Ankle Sprain or Strain

Completed · Phase 3

Conditions studied: Sprain, Strain

In brief

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.

Key facts

Study ID

NCT00351104

Run by

APR Applied Pharma Research s.a.

People needed

200

Starts

2006-06-01

Expected to finish

2007-03-01

Last updated by the study team

2020-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PPD — Austin, Texas, United States

Full record on ClinicalTrials.gov

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