Pharmacokinetic Study of Synera™ in Neonates and Infants

This study is currently recruiting participants.

Verified by ZARS Pharma Inc., September 2008

Sponsored by:	ZARS Pharma Inc.
Information provided by:	ZARS Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00747669

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 IV

Drug Information available for: Tetracaine Viractin Lidocaine

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
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

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 Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

One Synera Patch applied for 30 minutes.

Eligibility

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	Recruiting
Washington, District of Columbia, United States, 20010
Contact: Ivan Navarro-Quiroga, PhD 202-476-4970

Sponsors and Collaborators

ZARS Pharma Inc.

Investigators

Study Chair:

ZARS Clinical Development

ZARS Pharma

More Information

Responsible Party:	ZARS Pharma, Inc. ( EVP Clinical Development and Regulatory Affairs )
Study ID Numbers:	EN3274-401
Study First Received:	September 3, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00747669
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Tetracaine
Lidocaine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 14, 2009