NCT01224457

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2008

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

1.9 years

First QC Date

October 19, 2010

Last Update Submit

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

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
  • 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.

Sponsors & Collaborators

MeSH Terms

Interventions

Phenobarbital

Intervention Hierarchy (Ancestors)

BarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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 1, 2008

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

January 31, 2012

Record last verified: 2012-01