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• Status: Withdrawn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