Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the 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 wrist sprain, strain or contusion 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 wrist sprain, strain or contusion

• Meet baseline pain criterion

Exclusion Criteria:

• Open wound or infection at the site of injury

• Severe wrist injury or wrist fracture

• Presence or history of hand, wrist or forearm nerve impingement or palsies

• Use of NSAIDs or opioids within 12 - 24 hours of wrist injury

• Presence or history of peptic ulcers or GI bleeding

• History of intolerance to NSAIDs, acetaminophen, adhesives

• Positive pregnancy test

• Positive drug screen