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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Pain, Ankle Sprain

Intervention / Treatment
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* Drug: Diclofenac Sodium
* Drug: Matching Placebo Patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average pain during daily activity at Day 3 |  | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average pain during daily activity at Day 7 |  | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diclofenac, ankle sprain, acute pain, topical, patch, Acute Pain due to Mild to Moderate Ankle Sprain