Acute Pain Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries
Verified date | August 2010 |
Source | Cerimon Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 painful area.
Status | Completed |
Enrollment | 407 |
Est. completion date | December 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | PPD | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Cerimon Pharmaceuticals | PPD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in average pain during daily activity at Day 7 | Day 7 | No | |
Secondary | Change in average pain during daily activity at Day 14 | Day 14 | No |
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