Overview

Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
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 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 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