Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.

Neonatal Seizure Clinical Trial

Official title:

Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224457
• Other study ID #: 4-2008-0029
• Status: Completed
• Phase: N/A
• First received: October 19, 2010
• Last updated: January 26, 2012
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: January 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

The pharmacogenomic profiles of drug metabolizing enzymes play an important role in pharmacokinetics (PK) of drugs. Phenobarbital (PB), worldwidely used for neonatal seizure, is a drug that requires careful dose adjustments based on therapeutic drug monitoring. It was reported that phenobarbital (PB) metabolism was affected by CYP2C9 and CYP2C19 polymorphisms in adults. This study aims to evaluate the effects of the CYP2C9 and CYP2C19 genetic polymorphisms on PB PK in infants with neonatal seizure for an optimal dosing strategy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• Infant treated by phenobarbital monotherapy, diagnosed neonatal seizure

• Infant taken the drug concentration one more time

• given the informed consent

Exclusion Criteria:

• progressed CNS disorder

• severe systemic illness

• GOT/GPT level more than 2times of normal value,more than 3times elevation of BUN/creatinine level

• congenital hemolytic anemia

• genetic disorder

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Neonatal Seizure
• Seizures

Intervention

Drug:
• Phenobarbital
phenobarbital 20mg/kg iv infusion, after 24hours of loading, 2.5mg/kg bid daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pb drug concentration	pb drug concentration, CYP2C9/CYP2C19 polymorphism	48 hours after administering phenobarbital	No