Randomized Trial for Pharmacogenomics-Based Proton Pump Inhibitor Therapy in Children
Information source: Osaka University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux
Intervention: Lansoprazole (Drug)
Phase: Phase 2/Phase 3
Status: Not yet recruiting
Sponsored by: Osaka University Official(s) and/or principal investigator(s):
Junichi Azuma, MD, Study Chair, Affiliation: Graduate School of Pharmaceutical Sciences, Osaka University
Overall contact:
Masako Ohno, PhD, Phone: +81-6-6879-8163, Email: ohno@phs.osaka-u.ac.jp
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.
Clinical Details
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment
Eligibility
Minimum age: 1 Year.
Maximum age: 15 Years.
Gender(s): Both.
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
Locations and Contacts
Masako Ohno, PhD, Phone: +81-6-6879-8163, Email: ohno@phs.osaka-u.ac.jp
Osaka Medical Center, Osaka 558-8558, Japan
Osaka Medical Center and Research Institute for Maternal and Child Health, Izumi, Osaka 594-1101, Japan
Osaka University Hospital, Suita, Osaka 565-0871, Japan
Additional Information
Last updated: March 9, 2006
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