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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Osaka University
ClinicalTrials.gov Identifier:
NCT00299845
First received: March 6, 2006
Last updated: October 10, 2012
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux
Drug: Lansoprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Osaka University:

Enrollment: 0
  Eligibility

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299845

Locations
Japan
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Sponsors and Collaborators
Osaka University
Investigators
Study Chair: Junichi Azuma, MD Graduate School of Pharmaceutical Sciences, Osaka University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00299845     History of Changes
Other Study ID Numbers: PG-ped-LPZ-01
Study First Received: March 6, 2006
Last Updated: October 10, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Osaka University:
gastroesophageal reflux
children
lansoprazole
cytochrome P450 2C19 (CYP2C19)
pharmacogenomics
genetic polymorphisms
individualized medicine
pharmacokinetics/dynamics

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole
Proton Pump Inhibitors
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014