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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Cerimon Pharmaceuticals
• Collaborator: PPD
• Treatments: Diclofenac

Criteria

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