Trial | NCT00991068  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tetracaine lidocaine ...

  • Study Participants

    24
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 Started
Sep 30
2009
Primary Completion
Mar 31
2010
Study Completion
Mar 31
2010
Last Update
Mar 16
2012
Estimate

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

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.

Synera Experimental

Synera topical patch

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
No Results Posted