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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-12-31

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.

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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.

Conditions

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Acute Pain Soft Tissue Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diclofenac Sodium Patch

Group Type EXPERIMENTAL

Diclofenac Sodium

Intervention Type DRUG

Topical diclofenac patch applied once daily to area of pain

Topical Placebo Patch

Group Type PLACEBO_COMPARATOR

Matching Placebo Patch

Intervention Type DRUG

Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily

Interventions

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Diclofenac Sodium

Topical diclofenac patch applied once daily to area of pain

Intervention Type DRUG

Matching Placebo Patch

Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No