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This study has been withdrawn prior to enrollment.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

March 6, 2006
October 10, 2012
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Complete list of historical versions of study NCT00299845 on ClinicalTrials.gov Archive Site
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Randomized Trial for Pharmacogenomics-based Proton Pump Inhibitor Therapy in Children
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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.

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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastroesophageal Reflux
Drug: Lansoprazole
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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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
Both
1 Year to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00299845
PG-ped-LPZ-01
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Osaka University
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Study Chair: Junichi Azuma, MD Graduate School of Pharmaceutical Sciences, Osaka University
Osaka University
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP