Evaluate the Depth and Duration of Anesthesia

April 30, 2009 updated by: ZARS Pharma Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

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
    • California
      • San Diego, California, United States, 92037-7651
        • UCSD Medical Center, Thornton Hospital

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo Patch
placebo
Experimental: Synera
Drug: Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)
30 minute applicable on antecubital fossa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensory and pain depth measurements
Time Frame: 0, 30, 60, 90, 120 and 150 minutes
0, 30, 60, 90, 120 and 150 minutes
Dermal and thermal sensory testing evaluations
Time Frame: 0, 30, 60, 90, 120 and 150 minutes
0, 30, 60, 90, 120 and 150 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the safety and tolerability of the Synera topical patch compared with a matching heated placebo patch
Time Frame: Throughout the study
Throughout the study
Evaluate local effects on the skin at the site of patch application for dermal adverse events (AEs)
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

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

Sponsor

ZARS Pharma Inc.

Collaborators

Endo Pharmaceuticals

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

December 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

April 29, 2009

First Submitted That Met QC Criteria

April 30, 2009

First Posted (Estimate)

May 1, 2009

Study Record Updates

Last Update Posted (Estimate)

May 1, 2009

Last Update Submitted That Met QC Criteria

April 30, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN3274-101

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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