Ignite Creation Date:
2024-05-06 @ 7:33 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02557932
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2015-09-21
Brief Title:
Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H Pylori Eradication
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
Comparison of 7-day Proton Pump Inhibitor PPI-Clarithromycin Containing Triple Therapy and 10-day Bismuth Quadruple Therapy for Helicobacter Eradication as First-line Regimen Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-04
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:
In this randomized controlled trial we investigate the effect of 10-day bismuth quadruple therapy in comparison with that of 7-day PPI-based standard triple as 1st line treatment for H pylori
Detailed Description:
Current Helicobacter pylori management guidelines recommend proton-pump inhibitor PPI-Clarithromycin containing triple therapy as 1st line treatment However in Korea eradication rates of PPI-Clarithromycin containing triple therapy have been decreased to less than 80 due to increased clarithromycin resistance In areas of high clarithromycin resistance resistance rate more than 15 guidelines recommend bismuth quadruple therapy as a 1st line treatment for H pylori eradication Clarithromycin resistance rates reported from 157 to 421 in Korea thus bismuth quadruple therapy may be better 1st line treatment than PPI-Clarithromycin containing triple therapy However only one limited study was performed to compare effects of the both treatment regimens in Korea Thus studies evaluating the effect of 10-day bismuth quadruple therapy as the first line treatment for H pylori infection
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