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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux

Keywords

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gastroesophageal reflux children lansoprazole cytochrome P450 2C19 (CYP2C19) pharmacogenomics genetic polymorphisms individualized medicine pharmacokinetics/dynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lansoprazole

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Junichi Azuma, MD

Role: STUDY_CHAIR

Graduate School of Pharmaceutical Sciences, Osaka University

Locations

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Osaka University Hospital

Suita, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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PG-ped-LPZ-01

Identifier Type: -

Identifier Source: org_study_id