Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain (SUPPORT 2)

January 26, 2010 updated by: Cerimon Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diclofenac Sodium Patch
Drug: Diclofenac Sodium
Topical diclofenac patch applied once daily to area of pain
Placebo Comparator: Topical Placebo Patch
Drug: Matching Placebo Patch
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in average pain during daily activity at Day 3
Time Frame: Day 3
Day 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in average pain during daily activity at Day 7
Time Frame: Day 7
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerimon Pharmaceuticals

Collaborators

PPD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 24, 2009

First Submitted That Met QC Criteria

March 24, 2009

First Posted (Estimate)

March 25, 2009

Study Record Updates

Last Update Posted (Estimate)

January 28, 2010

Last Update Submitted That Met QC Criteria

January 26, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCF-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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