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

Acute Pain Clinical Trial

— WIND  

Official title:

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 Wrist Sprain, Strain or Contusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869063
• Other study ID #: DCF-005
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2009
• Last updated: January 26, 2010
• Start date: February 2009
• Est. completion date: September 2009

Study information

• Verified date: January 2010
• Source: Cerimon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Contusions

Intervention

Drug:
• Diclofenac Sodium Patch
Topical 1% diclofenac sodium patch, applied once daily for 7 days
• Matching Placebo Patch
Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days

Locations

Country	Name	City	State
United States	PPD	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Cerimon Pharmaceuticals	PPD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average pain during daily activity		Day 3	No
Secondary	Change in average pain during daily activity		Day 7	No