Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-19
Brief Title:
Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori
Sponsor:
Shandong University
Organization:
Shandong University
Study Overview
Official Title:
Triple Versus Quadruple Therapy With Amoxicillin and Tetracycline for the Eradication of Helicobacter Pylori A Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
SHARE2401
Brief Summary:
The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks The eradication rates adverse reaction rates and patient adherence were calculated
Detailed Description:
H pylori-positive patients without eradication history were recruited according to inclusion and exclusion criteria and randomized to the intervention
14-day quadruple regimen Vonoprazan 20mg bid Amoxicillin 1000mg bid Tetracycline 500mg qid Bismuth 220mg bid for 14 days 14-day triple regimen Vonoprazan 20mg bid Amoxicillin 1000mg bid Tetracycline 500mg qid 14 days 7-day triple regimen Vonoprazan 20mg bid Amoxicillin 1000mg bid Tetracycline 500mg qid 7 days Subjects were asked to record adverse events and 6 weeks after treatment 13C-urea breath test was tested for confirmation The eradication rates adverse reaction rates and patient adherence were calculated and analysed and the results were analysed to provide more information for eradication regimens of H pylori
14-day quadruple regimen Vonoprazan 20mg bid Amoxicillin 1000mg bid Tetracycline 500mg qid Bismuth 220mg bid for 14 days 14-day triple regimen Vonoprazan 20mg bid Amoxicillin 1000mg bid Tetracycline 500mg qid 14 days 7-day triple regimen Vonoprazan 20mg bid Amoxicillin 1000mg bid Tetracycline 500mg qid 7 days Subjects were asked to record adverse events and 6 weeks after treatment 13C-urea breath test was tested for confirmation The eradication rates adverse reaction rates and patient adherence were calculated and analysed and the results were analysed to provide more information for eradication regimens of H pylori
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