NCT01224457

Completed

Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of...

Yonsei University Source

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Other study identifiers

Sponsor study identifier

4-2008-0029

Study Type

interventional

Actual enrollment (reported)

52

Locations

0 countries

Sites

N/A

Timeline

Study Start

May 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2010

Actual (reported)

Study Completion

May 2010

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 52 participants
Study completion date: May 2010
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2008
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
April 2010
Actual (reported)
Study Completion
May 2010
Actual (reported)
First Submitted
October 19, 2010
Actual (reported)
First Posted
October 20, 2010
Actual (reported)

Last Updated: January 31, 2012
Status Verified: January 2012
Last Update Submitted: January 26, 2012

Conditions

Neonatal Seizure

Outcome Measures

Primary Outcomes (1)

pb drug concentration
pb drug concentration, CYP2C9/CYP2C19 polymorphism
48 hours after administering phenobarbital

Interventions

PhenobarbitalDrug

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

AgeUp to 1 Year

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Infant treated by phenobarbital monotherapy, diagnosed neonatal seizure
Infant taken the drug concentration one more time

Sponsors & Collaborators

Yonsei University
Otherlead

MeSH Terms

Interventions

Phenobarbital

Intervention Hierarchy (Ancestors)

BarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Enrollment

52 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 19, 2010

First Posted

October 20, 2010

Study Start

May 2008

Date type not reported

This date has not been verified as actual or estimated.

NCT01175668

Clonidine for Neonatal Abstinence Syndrome Study

Not ApplicableTerminated

NCT05257889

Neonatal Seizures in NICU of Assuit University Children's Hospital

Unknown

NCT01089504

Prophylactic Phenobarbital After Neonatal Seizures

Phase 4Terminated

NCT06211192

What Are the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures?

Completed

NCT04991779

AI-assisted cEEG Diagnosis of Neonatal Seizures in Neonatal Intensive Care Unit

Withdrawn

NCT07098728

Levetiracetam Versus Phenobarbital in Benzodiazepines Unresponsive Paediatric Prolonged Seizures

Not ApplicableRecruiting

given the informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

April 2010

Actual (reported)

Study Completion

May 2010

Actual (reported)

Last Updated

January 31, 2012

Record last verified: 2012-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01224457
Data provider: ClinicalTrials.gov
Source updated: 2012-01-31
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:42 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record