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Completed

NCT Number: NCT00991068

Open-Label 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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

International Clinical Research Institute

Overland Park, Kansas, 66211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch

Drug

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.

Primary outcomes

  1. Pain intensity

    Time frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal

Secondary outcomes

  1. Pain interference with activities (general, normal work, sleep)

    Time frame: Screening/Day 1, Day 8, and Day 15 or early withdrawal

Sponsors and collaborators

Lead sponsor

ZARS Pharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 7, 2009
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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