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

Phase 2

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch

• Registration Number: NCT00991068
• Lead Sponsor: ZARS Pharma Inc.

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2012-03
• Disposition First Submitted: 2012-03-14
• Disposition First Submitted QC: 2012-03-14
• Last Update Submitted: 2012-03-14
• Disposition First Posted: 2012-03-16
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Synera	Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch	Synera topical patch

Primary Outcome Measures

Name	Time	Method
Pain intensity	Screening/Day 1, Day 8, and Day 15 or early withdrawal

Secondary Outcome Measures

Name	Time	Method
Pain interference with activities (general, normal work, sleep)	Screening/Day 1, Day 8, and Day 15 or early withdrawal

Trial Locations

Locations (1)

International Clinical Research Institute; 🇺🇸 Overland Park, Kansas, United States