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Completed

NCT Number: NCT00891163

Evaluate the Depth and Duration of Anesthesia

The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing and thermal sensory testing evaluations), compared with a matching heated placebo patch.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCSD Medical Center, Thornton Hospital

San Diego, California, 92037-7651, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Had no known significant diseases
  • Normal 12-lead electrocardiogram
  • Willing to refrain from using any local topical preparations

Exclusion criteria

  • Taken over-the-counter (OTC) or prescription analgesics in any form within 24 hours
  • Known allergy or sensitivity to any component of the Synera patch, including lidocaine, sympathomimetic amines, other local anesthetics of the amide type, epinephrine, or other patch components
  • Had an active dermatological disease of any origin that may have interfered with their ability to participate

Treatment and study plan

Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)

Drug

30 minute applicable on antecubital fossa

Placebo Patch

Drug

placebo

Primary outcomes

  1. Sensory and pain depth measurements

    Time frame: 0, 30, 60, 90, 120 and 150 minutes

  2. Dermal and thermal sensory testing evaluations

    Time frame: 0, 30, 60, 90, 120 and 150 minutes

Secondary outcomes

  1. Assess the safety and tolerability of the Synera topical patch compared with a matching heated placebo patch

    Time frame: Throughout the study

  2. Evaluate local effects on the skin at the site of patch application for dermal adverse events (AEs)

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

ZARS Pharma Inc.

Industry

Collaborators

  • Endo USA Inc., a Keenova Therapeutics Company

Registry information

Official study title

A Randomized, Double-Blind, Two-Period, Crossover Study to Evaluate the Depth and Duration of Anesthesia of Synera™ Patches Compared to Placebo Patches Applied to Healthy Adult Volunteers

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 1, 2009
Registry last updated
May 1, 2009

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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