Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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The purpose of the study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome.

Detailed Description
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ZARS Pharma, Inc. has developed Synera® (lidocaine 70 mg and tetracaine 70 mg topical patch), a drug delivery patch that utilizes controlled heat to enhance the delivery of a local anesthetic formulation consisting of a eutectic mixture of lidocaine and tetracaine. Synera was approved by the Food and Drug Administration (FDA) on June 23, 2005 and is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodesiccation, and shave biopsy of skin lesions. The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate CTS.

Official Title
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An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Drug: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain associated with mild to moderate carpal tunnel syndrome in a single wrist Have recent (within 3 months) electrodiagnostic evidence of carpal tunnel syndrome (CTS) Exclusion Criteria: Have bilateral carpal tunnel syndrome Have another peripheral neuropathy in the affected limb Have had an injection into the carpal tunnel within 8 weeks Have had surgical release of the target wrist within previous 6 months Have electrodiagnostic evidence of severe CTS Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synera<br>Synera topical patch | Drug: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch<br>* Patients will apply a single Synera patch to the target wrist for 2 hours twice a day (ie, morning and evening applications) for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity |  | Screening/Day 1, Day 8, and Day 15 or early withdrawal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain interference with activities (general, normal work, sleep) |  | Screening/Day 1, Day 8, and Day 15 or early withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Mild to moderate Carpal Tunnel Syndrome