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Pharmacokinetic Study of Synera™ in Neonates and Infants

This study has suspended participant recruitment.
(Difficulty with enrollment)
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00747669
First received: September 3, 2008
Last updated: March 22, 2012
Last verified: March 2012
History of Changes
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Monitor the nature and frequency of adverse events [ Time Frame: 30 Hours ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00747669     History of Changes
Other Study ID Numbers: EN3274-401
Study First Received: September 3, 2008
Last Updated: March 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tetracaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013