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

October 19, 2010
January 26, 2012
May 2008
April 2010   (final data collection date for primary outcome measure)
pb drug concentration [ Time Frame: 48 hours after administering phenobarbital ] [ Designated as safety issue: No ]
pb drug concentration, CYP2C9/CYP2C19 polymorphism
Same as current
Complete list of historical versions of study NCT01224457 on ClinicalTrials.gov Archive Site
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Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.
Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.

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.

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Interventional
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Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Neonatal Seizure
Drug: Phenobarbital
phenobarbital 20mg/kg iv infusion, after 24hours of loading, 2.5mg/kg bid daily
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
May 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01224457
4-2008-0029
No
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP