Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion

Phase 3

Completed

• Conditions: Acute Pain
• Interventions: Drug: Diclofenac Sodium Patch; Drug: Matching Placebo Patch

• Registration Number: NCT00869063
• Lead Sponsor: Cerimon Pharmaceuticals

Brief Summary

The purpose of the 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 wrist sprain, strain or contusion when applied to the painful area.

Detailed Description

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with a mild to moderate wrist sprain, strain or contusion.

Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment to 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 also be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-26
• Last Update Posted: 2010-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• Male and female subjects 17 - 75 years of age
• Sustained recent, painful unilateral mild to moderate wrist sprain, strain or contusion
• Meet baseline pain criterion

Exclusion Criteria

• Open wound or infection at the site of injury
• Severe wrist injury or wrist fracture
• Presence or history of hand, wrist or forearm nerve impingement or palsies
• Use of NSAIDs or opioids within 12 - 24 hours of wrist injury
• Presence or history of peptic ulcers or GI bleeding
• History of intolerance to NSAIDs, acetaminophen, adhesives
• Positive pregnancy test
• Positive drug screen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac Sodium Patch	Diclofenac Sodium Patch	-
Placebo Patch	Matching Placebo Patch	-

Primary Outcome Measures

Name	Time	Method
Change in average pain during daily activity	Day 3

Secondary Outcome Measures

Name	Time	Method
Change in average pain during daily activity	Day 7

Trial Locations

Locations (1)

PPD; 🇺🇸 Austin, Texas, United States