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

Osaka University

Status and phase: Withdrawn; Phase 4

Conditions: Gastroesophageal Reflux

Treatments: Drug: Lansoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00299845

PG-ped-LPZ-01

Details and patient eligibility

About

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.

Sex: All

Ages: 1 to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)