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

Launched by CERIMON PHARMACEUTICALS · Mar 24, 2009

Keywords

ClinConnect Summary

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 reco...

Gender

ALL

Eligibility 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