Status:
COMPLETED
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)
Lead Sponsor:
Cerimon Pharmaceuticals
Collaborating Sponsors:
PPD Development, LP
Conditions:
Acute Pain
Soft Tissue Injury
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries when applied to the pa...
Detailed Description
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild to moderate soft tissue injuries. Eligible patients will be randomized (in a 1:1 ratio)...
Eligibility Criteria
Inclusion
- Male and female subjects 18-75 years of age
- Sustained recent, painful unilateral mild to moderate soft tissue injury (between the mid-bicep to wrist or mid-thigh to ankle)
- Meet baseline pain criterion
Exclusion
- Open wound or infection at site of injury
- Evidence of severe injury, including fracture or nerve injury
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00931866
Start Date
April 1 2009
End Date
December 1 2009
Last Update
August 16 2010
Active Locations (1)
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1
PPD
Austin, Texas, United States