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

Primary Purpose

Acute Pain, Ankle Sprain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Diclofenac Sodium
Matching Placebo Patch
Sponsored by
Cerimon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring diclofenac, ankle sprain, acute pain, topical, patch, Acute Pain due to Mild to Moderate Ankle Sprain

Eligibility Criteria

17 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PPD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diclofenac Sodium Patch

Topical Placebo Patch

Arm Description

Outcomes

Primary Outcome Measures

Change in average pain during daily activity at Day 3

Secondary Outcome Measures

Change in average pain during daily activity at Day 7

Full Information

First Posted
March 24, 2009
Last Updated
January 26, 2010
Sponsor
Cerimon Pharmaceuticals
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT00869180
Brief Title
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cerimon Pharmaceuticals
Collaborators
PPD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Ankle Sprain
Keywords
diclofenac, ankle sprain, acute pain, topical, patch, Acute Pain due to Mild to Moderate Ankle Sprain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac Sodium Patch
Arm Type
Experimental
Arm Title
Topical Placebo Patch
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Diclofenac Sodium
Intervention Description
Topical diclofenac patch applied once daily to area of pain
Intervention Type
Drug
Intervention Name(s)
Matching Placebo Patch
Intervention Description
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily
Primary Outcome Measure Information:
Title
Change in average pain during daily activity at Day 3
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Change in average pain during daily activity at Day 7
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
PPD
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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