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Evaluate the Depth and Duration of Anesthesia

This study has been completed.
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by:
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00891163
First received: April 29, 2009
Last updated: April 30, 2009
Last verified: April 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
  • Dermal and thermal sensory testing evaluations [ Time Frame: 0, 30, 60, 90, 120 and 150 minutes ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • Evaluate local effects on the skin at the site of patch application for dermal adverse events (AEs) [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Senior Director, Clinical R&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00891163     History of Changes
Other Study ID Numbers: EN3274-101
Study First Received: April 29, 2009
Last Updated: April 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:
Topical anesthesia
Analgesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014