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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00299845
First Posted: March 7, 2006
Last Update Posted: October 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Osaka University
  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: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Osaka University:

Enrollment: 0
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00299845     History of Changes
Other Study ID Numbers: PG-ped-LPZ-01
First Submitted: March 6, 2006
First Posted: March 7, 2006
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