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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01224457
First received: October 19, 2010
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Neonatal Seizure
 Drug: Phenobarbital

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.

Resource links provided by NLM:

MedlinePlus related topics: Seizures
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • pb drug concentration [ Time Frame: 48 hours after administering phenobarbital ] [ Designated as safety issue: No ]
    pb drug concentration, CYP2C9/CYP2C19 polymorphism


Enrollment: 52
Study Start Date: May 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Phenobarbital
    phenobarbital 20mg/kg iv infusion, after 24hours of loading, 2.5mg/kg bid daily
  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01224457     History of Changes
Other Study ID Numbers: 4-2008-0029
Study First Received: October 19, 2010
Last Updated: January 26, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Phenobarbital
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 19, 2013