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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00299845

Enrollment

Registered

2006-03-07

Start date

Unknown

Completion date

Unknown

Last updated

2012-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

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

Brief summary

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.

Interventions

DRUGLansoprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 15 Years

Healthy volunteers

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026