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

Acute Pain Clinical Trial

— SUPPORT 2  

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 Ankle Sprain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869180
• Other study ID #: DCF-004
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2009
• Last updated: January 26, 2010
• Start date: February 2009
• Est. completion date: August 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: August 2009
• Est. primary completion date: June 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 ankle sprain

• Meet baseline pain criterion

Exclusion Criteria:

• Open wound or infection at site of injury

• Evidence of severe injury or ankle fracture

• 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

Study Design

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

Related Conditions & MeSH terms

• Acute Pain
• Ankle Injuries
• Ankle Sprain

Intervention

Drug:
• Diclofenac Sodium
Topical diclofenac patch applied once daily to area of pain
• Matching Placebo Patch
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily

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 at Day 3		Day 3	No
Secondary	Change in average pain during daily activity at Day 7		Day 7	No