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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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 Wrist Sprain, Strain or Contusion

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Diclofenac Sodium Patch
* 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 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

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 Patch<br>* Topical 1% diclofenac sodium patch, applied once daily for 7 days<br>|
| Placebo Comparator: Placebo Patch<br> | Drug: Matching Placebo Patch<br>* Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days<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 |  | Day 3 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wrist, sprain, strain, contusion, diclofenac, patch, acute pain, acute pain due to mild to moderate wrist sprain, strain or contusion