Pharmacokinetic Study of Synera™ in Neonates and Infants

Pain Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00747669
• Other study ID #: EN3274-401
• Status: Suspended
• Phase: Phase 4
• First received: September 3, 2008
• Last updated: March 22, 2012
• Start date: September 2008
• Est. completion date: April 2013

Study information

• Verified date: March 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 11
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• lidocaine 70mg and tetracaine 70mg topical patch
One Synera Patch applied for 30 minutes.

Locations

Country	Name	City	State
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera		30 hours	No
Secondary	Monitor the nature and frequency of adverse events		30 Hours	Yes