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

Carpal Tunnel Syndrome Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00991068
Study type Interventional
Source ZARS Pharma Inc.
Contact
Status Completed
Phase Phase 2
Start date September 2009
Completion date March 2010
View Details
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