Gastroesophageal Reflux Clinical Trial
| NCT number | NCT00299845 |
| Other study ID # | PG-ped-LPZ-01 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 4 |
| First received | March 6, 2006 |
| Last updated | October 10, 2012 |
| Verified date | September 2006 |
| Source | Osaka University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 15 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Osaka University Hospital | Suita | Osaka |
| Lead Sponsor | Collaborator |
|---|---|
| Osaka University |
Japan,
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