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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2005 by Osaka University. Recruitment status was Not yet recruiting

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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: GERD

Drug Information available for: Lansoprazole

U.S. FDA Resources

Further study details as provided by Osaka University:

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 and Research Institute for Maternal and Child Health	Recruiting
Izumi, Osaka, Japan, 594-1101
Osaka University Hospital	Not yet recruiting
Suita, Osaka, Japan, 565-0871
Osaka Medical Center	Not yet recruiting
Osaka, Japan, 558-8558

Sponsors and Collaborators

Osaka University

Investigators

Study Chair:

Junichi Azuma, MD

Graduate School of Pharmaceutical Sciences, Osaka University

More Information

No publications provided

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

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole
Proton Pump Inhibitors

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012