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

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

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Synera
  • Synera topical patch

Primary Measures

• Pain intensity
  • Time Frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal
    Safety Issue?: Yes

Secondary Measures

• Pain interference with activities (general, normal work, sleep)
  • Time Frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: ZARS Pharma Inc. Industry

Overall Clinical Trial Officials and Contacts

Srinivas Nalamachu, MD Principal Investigator International Clinical Research Institute  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00991068

Study ID Number: SC-201

ClinicalTrials.gov Identifier: NCT00991068

Health Authority: United States: Food and Drug Administration