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

First Received: March 6, 2006 Last Updated: March 9, 2006 History of Changes

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

No publications provided

Study ID Numbers:	PG-ped-LPZ-01
Study First Received:	March 6, 2006
Last Updated:	March 9, 2006
ClinicalTrials.gov Identifier:	NCT00299845 History of Changes
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
Proton Pump Inhibitors
Esophageal Disorder

Gastrointestinal Diseases
Lansoprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders

Deglutition Disorders
Digestive System Diseases
Proton Pump Inhibitors
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Lansoprazole

ClinicalTrials.gov processed this record on May 06, 2009