Status:
COMPLETED
Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome
Lead Sponsor:
ZARS Pharma Inc.
Conditions:
Carpal Tunnel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 formulat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00991068
Start Date
September 1 2009
End Date
March 1 2010
Last Update
March 16 2012
Active Locations (1)
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1
International Clinical Research Institute
Overland Park, Kansas, United States, 66211