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

Phase 4

Withdrawn

• Conditions: Gastroesophageal Reflux

• Registration Number: NCT00299845
• Lead Sponsor: Osaka University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-06
• Study First Submitted QC: 2006-03-06
• Study First Posted: 2006-03-07
• Status Verified: 2006-09
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan