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

Information source: ZARS Pharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carpal Tunnel Syndrome

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

Phase: Phase 2

Status: Completed

Sponsored by: ZARS Pharma Inc.

Official(s) and/or principal investigator(s):
Srinivas Nalamachu, MD, Principal Investigator, Affiliation: International Clinical Research Institute

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 Details

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

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

Primary outcome: Pain intensity

Secondary outcome: Pain interference with activities (general, normal work, sleep)

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

International Clinical Research Institute, Overland Park, Kansas 66211, United States
Additional Information

Starting date: September 2009
Last updated: March 14, 2012

Page last updated: August 23, 2015

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