Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01887249
Status:
COMPLETED
Last Update Posted:
2013-08-13
First Post:
2013-06-24
Brief Title:
15-day Sequential Therapy for Helicobacter Pylori Infection in Korea
Sponsor:
Seoul National University Bundang Hospital
Organization:
Seoul National University Bundang Hospital
Study Overview
Official Title:
Randomized Clinical Trial the Comparison of 15-day Sequential and 10-day Sequential Therapy to PPI-based Triple Therapy for Helicobacter Pylori Infection in Korea
Status:
COMPLETED
Status Verified Date:
2013-08
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:
10-day sequential therapy was not sufficient to overcome tough situation for H pylori eradication in Korea due to high antimicrobial resistance The present investigators assumed that doubling duration of second phase of sequential therapy might have more potent bactericidal efficacy than previous 10-day sequential regimen But 15-day regimen with initial 5-day PPI with amoxicillin followed by remaining 10-day PPI clarithromycin with metronidazole was not ever tested before Moreover whether extending the sequential therapy to 15-day might be more effective than 10-day sequential therapy is unknown especially in Korea From this background the present investigators prepared clinical trials regarding modified sequential therapy which was extending the treatment duration to 15 days compared than previous 10-day sequential therapy regimen In addition pre-treatment antimicrobial susceptibility testing was performed to find the possibility to overcome antimicrobial resistance
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