Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics... | NCT01224457

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

NCT01224457

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Jan 31, 2012Estimated

Enrollment

52Actual

Phase

Not Applicable

Conditions

Neonatal Seizure

Interventions

Phenobarbital

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Apr 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Oct 19, 2010

First Submission Date that Met QC Criteria

Oct 19, 2010

First Posted Date

Oct 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2012

Last Update Posted Date

Jan 31, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phenobarbital	Drug	phenobarbital 20mg/kg iv infusion, after 24hours of loading, 2.5mg/kg bid daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pb drug concentration	pb drug concentration, CYP2C9/CYP2C19 polymorphism	48 hours after administering phenobarbital

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Year

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010634	Phenobarbital

Ancestor Terms

ID	Term
D001463	Barbiturates
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

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Browse Branches

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