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

Osaka University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Gastroesophageal Reflux

Interventions

LansoprazoleDRUG

Eligibility

Sex: ALLMin age: 1 YearMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Osaka University Hospital

Suita, Osaka, Japan

Data from ClinicalTrials.gov

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