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Evaluate the Depth and Duration of Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00891163
First Posted: May 1, 2009
Last Update Posted: May 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Endo Pharmaceuticals
Information provided by:
ZARS Pharma Inc.
  Purpose
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.

Condition Intervention Phase
Pain Drug: Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine) Drug: Placebo Patch Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • Sensory and pain depth measurements [ Time Frame: 0, 30, 60, 90, 120 and 150 minutes ]
  • Dermal and thermal sensory testing evaluations [ Time Frame: 0, 30, 60, 90, 120 and 150 minutes ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of the Synera topical patch compared with a matching heated placebo patch [ Time Frame: 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 ]

Enrollment: 25
Study Start Date: December 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Synera Drug: Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)
30 minute applicable on antecubital fossa
Placebo Comparator: Placebo Drug: Placebo Patch
placebo

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891163


Locations
United States, California
UCSD Medical Center, Thornton Hospital
San Diego, California, United States, 92037-7651
Sponsors and Collaborators
ZARS Pharma Inc.
Endo Pharmaceuticals
  More Information

Responsible Party: Senior Director, Clinical R&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00891163     History of Changes
Other Study ID Numbers: EN3274-101
First Submitted: April 29, 2009
First Posted: May 1, 2009
Last Update Posted: May 1, 2009
Last Verified: April 2009

Keywords provided by ZARS Pharma Inc.:
Topical anesthesia
Analgesia

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Tetracaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action


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