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

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase III Study of the Efficacy, Tolerability and Safety of Ketoprofen Topical Patch, 20% (KTP) in the Treatment of Pain Associated With Grade 1 or Grade 2 Ankle Sprain or Strain

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

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 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a follow-up assessment will be conducted by telephone on Day 28. At each visit through Day 14, patients will rate their average pain intensity during daily activities and while at rest using an 11-point scale, and will rate their functional disability. Patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as rescue medication

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