Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area.

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild or moderate ankle sprains.

Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice 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.

Inclusion Criteria:

• Male and female subjects 17 - 75 years of age
• Sustained recent, painful unilateral mild to moderate ankle sprain
• Meet baseline pain criterion

Exclusion Criteria:

• Open wound or infection at site of injury
• Evidence of severe injury or ankle fracture
• Use of oral NSAIDs or opioids within 12 - 24 hours of injury
• Presence or history of peptic ulcers or GI bleeding
• A history of intolerance to NSAIDs, acetaminophen, adhesives
• Positive pregnancy test
• Positive drug screen