CClinicalTrials.gg
WithdrawnNCT00299845Updated Oct 11, 2012

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

A Phase 4 interventional study of Lansoprazole in Gastroesophageal Reflux, sponsored by Osaka University. Withdrawn at 1 site in Japan. Open to participants aged 1 Year to 15 Years. Per ClinicalTrials.gov, last updated 2012-10-11.

Sponsored by Osaka University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
1 Year to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastroesophageal Reflux

Keywords

  • gastroesophageal reflux
  • children
  • lansoprazole
  • cytochrome P450 2C19 (CYP2C19)
  • pharmacogenomics
  • genetic polymorphisms
  • individualized medicine
  • pharmacokinetics/dynamics
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Osaka University is the lead sponsor of 33 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Serious hepatic disease, pulmonary disease, renal disease and blood disorder
  • Inadequate clinical conditions
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • DrugLansoprazole
06

Study locations

1 site
  • Osaka University Hospital
    Suita, Osaka 565-0871, Japan
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00299845
Lead sponsor
Osaka University
First posted
Mar 7, 2006
Last update
Oct 11, 2012

Study contacts

Junichi Azuma, MD
study chair · Graduate School of Pharmaceutical Sciences, Osaka University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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