NCT00931866

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Cerimon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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) 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.

Conditions

• Acute Pain
• Soft Tissue Injury

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium	Topical diclofenac patch applied once daily to area of pain
DRUG	Matching Placebo Patch	Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2009-07-02
• Last updated: 2010-08-16

Locations

1 site across 1 country: United States