Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06349486
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-04-01
Brief Title:
Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication
Sponsor:
Kaohsiung Medical University
Organization:
Kaohsiung Medical University
Study Overview
Official Title:
Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy in the First-line Anti-H Pylori Treatment
Status:
RECRUITING
Status Verified Date:
2024-04
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:
1 Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H pylori infection
2 To investigate the impacts of antibiotic resistance of H pylori as well as CYP3A4 CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H pylori treatments
2 To investigate the impacts of antibiotic resistance of H pylori as well as CYP3A4 CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H pylori treatments
Detailed Description:
For this multi-center randomized open-label superiority trial we will recruit 780 adult patients with H pylori infection from ten medical centers or regional hospitals in Taiwan Using a computer generated randomized sequence we randomly allocate patients 111 block size of six to either 14-day bismuth-amoxicillin-vonoprazan triple therapy 14-day vonoprazan dual therapy or 14-day rabeprazole-triple therapy Patients are asked to return at the second week to assess drug adherence and adverse events Post-treatment H pylori status is assessed by 13C-urea breath test at week 6 Participants with failure of H pylori eradication will randomly receive either 14-day vonoprazan-based or 14-day esomeprazole-based bismuth quadruple therapy Finally the rates of eradication and adverse events will be compared between groups by chi-square test Additionally the effects of antibiotic resistances of H pylori as well as CYP3A4 CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of above first-line and second-line anti-H pylori treatments are assessed by multivariate analysis
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