Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)
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.
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) to receive double-blind treatment with
 either the diclofenac topical patch or a matching placebo patch to be applied once daily for
 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a
 follow-up assessment will be conducted on Day 21. Patients will complete an electronic diary
 in which assessments including pain intensity and pain relief will be recorded twice daily.
 Functional disability and global impression of change will be recorded in the diary at study
 visits, ratings of the quality of sleep will be recorded in the diary each morning, and the
 use of study treatment and rescue medication will be recorded in the diary each day.
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