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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: APR Applied Pharma Research s.a.; Endo Pharmaceuticals
• Treatments: Ketoprofen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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