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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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Dexlansoprazole
Lansoprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014