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

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ClinicalTrials.gov Identifier: NCT01224457
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):

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
Neonatal Seizure Drug: Phenobarbital

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
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 2008
Primary Completion Date : April 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. pb drug concentration [ Time Frame: 48 hours after administering phenobarbital ]
    pb drug concentration, CYP2C9/CYP2C19 polymorphism

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
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
More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01224457     History of Changes
Other Study ID Numbers: 4-2008-0029
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers