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

Sponsor

Osaka University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00299845

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux	Drug: Lansoprazole	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 15 Years

Sexes Eligible for Study:

All

Accepts 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.