Ignite Creation Date:
2024-05-06 @ 7:10 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02487511
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2015-06-25
Brief Title:
Eradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy
Sponsor:
StPauls Hospital Korea
Organization:
StPauls Hospital Korea
Study Overview
Official Title:
Comparison of the Eradication Rate Between 1- and 2-Week PPI Containing Therapies for Helicobacter Pylori Eradication
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
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:
It is recommended as the first line treatment regimen to eradicate Helicobacter pylori HP 7 or 14 days treatment of proton pump inhibitor PPI based triple therapy consisting of one PPI and two antibiotics clarithromycin and amoxicillin In the case of treatment failure 7 or 14 days of quadruple therapy PPImetronidazoletetracyclinebismuth is recommended
This study aims to investigate which duration would be better for eradication of HP The study design is a randomized controlled trial The patients were randomly assigned to 7 days or 14 days treatment groups Primary endpoint was the eradication rate of PPI based triple therapy Secondary endpoints were to compare the rate of drug compliance and side effects in both groups
This study aims to investigate which duration would be better for eradication of HP The study design is a randomized controlled trial The patients were randomly assigned to 7 days or 14 days treatment groups Primary endpoint was the eradication rate of PPI based triple therapy Secondary endpoints were to compare the rate of drug compliance and side effects in both groups
Detailed Description:
The recommended duration of triple therapy is typically 10 to 14 days in the United States and 7 days in Europe In Korea it is recommended as the first line treatment regimen 7 or 14 days treatment of proton pump inhibitor PPI based triple therapy consisting of one PPI and two antibiotics clarithromycin and amoxicillin In case for treatment failure which is often related to Helicobacter pylori HP resistance to clarithromycin or metronidazole bismuth-based quadruple therapy is commonly used as second-line therapy however the eradication rates was widely ranged according to the treatment duration
The objective of the study is to investigate whether treatment duration would affect the eradication rate of HP as a PPI based triple therapy 1st line therapy and a bismuth-based quadruple therapy 2nd line therapy
The objective of the study is to investigate whether treatment duration would affect the eradication rate of HP as a PPI based triple therapy 1st line therapy and a bismuth-based quadruple therapy 2nd line therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None