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

March 14, 2012 updated by: ZARS Pharma Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • International Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Synera
Synera topical patch
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity
Time Frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal
Screening/Day 1, Day 8, and Day 15 or early withdrawal

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain interference with activities (general, normal work, sleep)
Time Frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal
Screening/Day 1, Day 8, and Day 15 or early withdrawal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZARS Pharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 6, 2009

First Submitted That Met QC Criteria

October 6, 2009

First Posted (Estimate)

October 7, 2009

Study Record Updates

Last Update Posted (Estimate)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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