Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197418
Status:
UNKNOWN
Last Update Posted:
2006-03-21
First Post:
2005-09-12
Brief Title:
Second Line Therapy for the Cure of Helicobacter Pylori H Pylori Infection
Sponsor:
Hamamatsu University
Organization:
Hamamatsu University
Study Overview
Official Title:
Dual Therapy With High-Dose of Rabeprazole and Amoxicilline Versus Triple Therapy With Rabeprazole Amoxicilline and Metronidazole as the Second Line Therapy for the Cure of H Pylori Infection
Status:
UNKNOWN
Status Verified Date:
2003-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Proton pump inhibitors PPIs are mainly metabolized in the liver by CYP2C19 one of the cytochrome P450 isoenzymes which shows a genetic polymorphism associated with enzyme activities The most essential role of a PPI in H pylori eradication therapy is to make antibiotics more stable and bioavailable in the stomach by raising intragastric pH to neutral levels
Most patients who have failed in the eradication of H pylori infection by triple therapy with a PPI amoxicillin AMPC and clarithromycin CAM at standard doses have extensive metabolizer EM genotypes of CYP2C19 andor are infected with CAM-resistant strains of H pylori
Four-times daily dosing of a PPI could achieve complete gastric acid inhibition Dual therapy with 4-times daily dosing of a PPI and AMPC could yield sufficient re-eradication rates in patients with EM genotype of CYP2C19
Metronidazole MNZ-based re-eradication therapy such as triple PPIAMPCMNZ therapy also achieved high eradication rates and has been recommended as the second line therapy in Japan But carcinogenic actions of MNZ have been unclear
The purpose of this study is to compare the re-eradication rates of H pylori infection by the dual high-dose PPIAMPC therapy and triple PPIAMPCMNZ therapy and to validate the efficacies of these re-eradication regimens as second line eradication therapies
Most patients who have failed in the eradication of H pylori infection by triple therapy with a PPI amoxicillin AMPC and clarithromycin CAM at standard doses have extensive metabolizer EM genotypes of CYP2C19 andor are infected with CAM-resistant strains of H pylori
Four-times daily dosing of a PPI could achieve complete gastric acid inhibition Dual therapy with 4-times daily dosing of a PPI and AMPC could yield sufficient re-eradication rates in patients with EM genotype of CYP2C19
Metronidazole MNZ-based re-eradication therapy such as triple PPIAMPCMNZ therapy also achieved high eradication rates and has been recommended as the second line therapy in Japan But carcinogenic actions of MNZ have been unclear
The purpose of this study is to compare the re-eradication rates of H pylori infection by the dual high-dose PPIAMPC therapy and triple PPIAMPCMNZ therapy and to validate the efficacies of these re-eradication regimens as second line eradication therapies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None