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Pharmacokinetic Study of Synera™ in Neonates and Infants

This study has suspended participant recruitment.
(Difficulty with enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00747669
First Posted: September 5, 2008
Last Update Posted: March 23, 2012
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.
Information provided by (Responsible Party):
ZARS Pharma Inc.
  Purpose
This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.

Condition Intervention Phase
Pain Drug: lidocaine 70mg and tetracaine 70mg topical patch Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pharmacokinetic Study of Synera™ (Lidocaine 70 mg and Tetracaine 70 mg Topical Patch) to Evaluate the Systemic Exposure to Lidocaine and Tetracaine in Neonates and Infants

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera [ Time Frame: 30 hours ]

Secondary Outcome Measures:
  • Monitor the nature and frequency of adverse events [ Time Frame: 30 Hours ]

Estimated Enrollment: 11
Study Start Date: September 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lidocaine 70mg and tetracaine 70mg topical patch
    One Synera Patch applied for 30 minutes.
    Other Name: Synera
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be an infant of 1 to 4 months of age and weigh at least 2.5 kg or a neonate of 0 to 4 weeks postnatal age with a gestation period of at least 37 weeks, and weigh at least 1.8 kg.
  • Subject is scheduled to have a medically indicated minor superficial procedure for which topical local anesthesia would provide a benefit.
  • Subject has or will have an indwelling vascular access catheter for blood sampling at the time of the procedure visit. The indwelling vascular access catheter placement must be necessary for medical reasons other than the purposes of this study.
  • The additional blood draws for the purposes of this study do not pose more than a minor risk to the health and welfare of the subject.

Exclusion Criteria:

  • Subject has known allergies or sensitivities to any component of Synera.
  • Subject has clinically significant laboratory abnormalities.
  • Subject has known multiple allergies that could indicate hypersensitive skin.
  • Subject has known active atopic dermatitis at or near the patch application site.
  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): NCT00747669


Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
Study Chair: ZARS Clinical Development ZARS Pharma
  More Information

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00747669     History of Changes
Other Study ID Numbers: EN3274-401
First Submitted: September 3, 2008
First Posted: September 5, 2008
Last Update Posted: March 23, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
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