Status:
COMPLETED
Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion
Lead Sponsor:
Cerimon Pharmaceuticals
Collaborating Sponsors:
PPD Development, LP
Conditions:
Acute Pain
Eligibility:
All Genders
17-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with a mild to moderate wrist sprain, strain or contusion. Eligible patients will be randomized (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00869063
Start Date
February 1 2009
End Date
September 1 2009
Last Update
January 28 2010
Active Locations (1)
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1
PPD
Austin, Texas, United States, 78704