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

ZARS Pharma Inc.24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carpal Tunnel Syndrome

Interventions

Synera (lidocaine 70 mg and tetracaine 70 mg) topical patchDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

International Clinical Research Institute

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Pain intensity

Time frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal

Secondary Outcomes

Pain interference with activities (general, normal work, sleep)

Time frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.