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
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