Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)

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 mild to moderate soft tissue injuries 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 to moderate soft tissue injuries. 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 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a follow-up assessment will be conducted on Day 21. Patients will complete an electronic diary in which assessments including pain intensity and pain relief will be recorded twice daily. Functional disability and global impression of change will be recorded in the diary at study visits, 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 Soft Tissue Injuries

Conditions
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Acute Pain, Soft Tissue Injury

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 18-75 years of age Sustained recent, painful unilateral mild to moderate soft tissue injury (between the mid-bicep to wrist or mid-thigh to ankle) Meet baseline pain criterion Exclusion Criteria: Open wound or infection at site of injury Evidence of severe injury, including fracture or nerve injury 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: 18 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 7 |  | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average pain during daily activity at Day 14 |  | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diclofenac, acute pain, patch, Acute Pain due to Mild to Moderate Soft Tissue Injury, topical