- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01224457
Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.
January 26, 2012 updated by: Yonsei University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pb drug concentration
Time Frame: 48 hours after administering phenobarbital
|
pb drug concentration, CYP2C9/CYP2C19 polymorphism
|
48 hours after administering phenobarbital
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
October 19, 2010
First Submitted That Met QC Criteria
October 19, 2010
First Posted (Estimate)
October 20, 2010
Study Record Updates
Last Update Posted (Estimate)
January 31, 2012
Last Update Submitted That Met QC Criteria
January 26, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Seizures
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Hypnotics and Sedatives
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Cytochrome P-450 CYP2B6 Inducers
- Phenobarbital
Other Study ID Numbers
- 4-2008-0029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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