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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00991068
First received: October 6, 2009
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Carpal Tunnel Syndrome
Drug: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain interference with activities (general, normal work, sleep) [ Time Frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991068

Locations
United States, Kansas
International Clinical Research Institute
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
Principal Investigator: Srinivas Nalamachu, MD International Clinical Research Institute
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00991068     History of Changes
Other Study ID Numbers: SC-201
Study First Received: October 6, 2009
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:
Pain
Mild to moderate Carpal Tunnel Syndrome

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Syndrome
Cumulative Trauma Disorders
Disease
Median Neuropathy
Mononeuropathies
Nerve Compression Syndromes
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on November 19, 2014