Pharmacokinetic Study of Synera⢠in Neonates and Infants
Information source: ZARS Pharma Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: lidocaine 70mg and tetracaine 70mg topical patch (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: ZARS Pharma Inc. Official(s) and/or principal investigator(s):
ZARS Clinical Development, Study Chair, Affiliation: ZARS Pharma
Summary
This study will measure the amount of lidocaine and tetracaine in the blood after a 30
minute application of Synera.
Clinical Details
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
Study design: Basic Science, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera
Secondary outcome: Monitor the nature and frequency of adverse events
Eligibility
Minimum age: N/A.
Maximum age: 4 Months.
Gender(s): Both.
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.
Locations and Contacts
Children's National Medical Center, Washington, District of Columbia 20010, United States; Recruiting
Ivan Navarro-Quiroga, PhD, Phone: 202-476-4970
Additional Information
Starting date: September 2008
Ending date: December 2009
Last updated: October 8, 2009
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