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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01224457
• Collaborator: (none)
• Enrollment: 52
• Duration (Months): 24

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Seizure	Drug: Phenobarbital	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: May 1, 2010

Outcome Measures

Primary Outcome Measures

1. pb drug concentration [48 hours after administering phenobarbital]

   pb drug concentration, CYP2C9/CYP2C19 polymorphism

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Year
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01224457
• Other Study ID Numbers: 4-2008-0029
• First Posted: Oct 20, 2010
• Last Update Posted: Jan 31, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Seizures; Phenobarbital

Study Results

No Results Posted as of Jan 31, 2012