Back to resultsRandomized Trial for Pharmacogenomics-based Proton Pump Inhibitor Therapy in Children
Primary Purpose
Gastroesophageal Reflux
Status
Withdrawn
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Lansoprazole
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring gastroesophageal reflux, children, lansoprazole, cytochrome P450 2C19 (CYP2C19), pharmacogenomics, genetic polymorphisms, individualized medicine, pharmacokinetics/dynamics
Eligibility 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
Sites / Locations
- Osaka University Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00299845
Brief Title
Randomized Trial for Pharmacogenomics-based Proton Pump Inhibitor Therapy in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Osaka University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
gastroesophageal reflux, children, lansoprazole, cytochrome P450 2C19 (CYP2C19), pharmacogenomics, genetic polymorphisms, individualized medicine, pharmacokinetics/dynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junichi Azuma, MD
Organizational Affiliation
Graduate School of Pharmaceutical Sciences, Osaka University
Official's Role
Study Chair
Facility Information:
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Randomized Trial for Pharmacogenomics-based Proton Pump Inhibitor Therapy in Children
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