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

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ClinicalTrials.gov Identifier: NCT00299845
Recruitment Status : Withdrawn
First Posted : March 7, 2006
Last Update Posted : October 11, 2012
Sponsor:
Information provided by:
Osaka University

Brief 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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: Lansoprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources





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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00299845     History of Changes
Other Study ID Numbers: PG-ped-LPZ-01
First Posted: March 7, 2006    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: September 2006

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
Dexlansoprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action