Overview

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

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Osaka University
Treatments:
Dexlansoprazole
Lansoprazole
Proton Pump Inhibitors
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