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

ZARS Pharma

Status and phase: Completed; Phase 2

Conditions: Carpal Tunnel Syndrome

Treatments: Drug: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00991068

SC-201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Synera

Experimental group

Description:

Synera topical patch

Treatment:

Drug: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch