NCT00869180

Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain

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 Ankle Sprain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Cerimon Pharmaceuticals · Industry
• Sex: All
• Age: 17 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 acute pain due to mild to moderate ankle sprains when applied to the painful area.

Detailed description

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild or moderate ankle sprains. 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 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. 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
• Ankle Sprain

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: 2009-02-01
• Primary completion: 2009-06-01
• Completion: 2009-08-01
• First posted: 2009-03-25
• Last updated: 2010-01-28

Locations

1 site across 1 country: United States