Randomized Trial for Pharmacogenomics-Based Proton Pump Inhibitor Therapy in Children

This study is not yet open for participant recruitment.

Verified by Osaka University, November 2005

Sponsored by:	Osaka University
Information provided by:	Osaka University
ClinicalTrials.gov Identifier:	NCT00299845

Purpose

Proton pump inhibitors are administered to children as off-label use in Japan. The purpose of this study is to evaluate the effects of CYP2C19 genotypes on pharmacokinetic /pharmacodynamic profiles of PPI in children. The results will provide the beneficial information for the individualized medicine of PPI in children.

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: Lansoprazole	Phase II Phase III

MedlinePlus related topics: GERD

Drug Information available for: Lansoprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment

Eligibility

Ages Eligible for Study:	1 Year to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with gastroesophageal reflux
The patient’s parent or guardian gives written informed consent including pharmacogenomic analysis
The patient is willing and able to give assent to participate.

Exclusion Criteria:

Serious hepatic disease, pulmonary disease, renal disease and blood disorder
Inadequate clinical conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299845

Contacts

Contact: Masako Ohno, PhD

+81-6-6879-8163

ohno@phs.osaka-u.ac.jp

Locations

Japan
Osaka Medical Center
Osaka, Japan, 558-8558
Japan, Osaka
Osaka Medical Center and Research Institute for Maternal and Child Health
Izumi, Osaka, Japan, 594-1101
Osaka University Hospital
Suita, Osaka, Japan, 565-0871

Sponsors and Collaborators

Osaka University

Investigators

Study Chair:

Junichi Azuma, MD

Graduate School of Pharmaceutical Sciences, Osaka University

More Information

Study ID Numbers:	PG-ped-LPZ-01
Study First Received:	March 6, 2006
Last Updated:	March 9, 2006
ClinicalTrials.gov Identifier:	NCT00299845
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Osaka University:

gastroesophageal reflux
children
lansoprazole
cytochrome P450 2C19 (CYP2C19)

pharmacogenomics
genetic polymorphisms
individualized medicine
pharmacokinetics/dynamics

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Lansoprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009