Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05196945
Status:
UNKNOWN
Last Update Posted:
2022-02-17
First Post:
2022-01-08
Brief Title:
Vonoprazan Fumarate in Combination With Amoxicillin for the First-line Eradication of Helicobacter Pylori -- a Multicenter Randomized Parallel Controlled Study
Sponsor:
Sixth Affiliated Hospital Sun Yat-sen University
Organization:
Sixth Affiliated Hospital Sun Yat-sen University
Study Overview
Official Title:
Vonoprazan Fumarate in Combination With Amoxicillin for the First-line Eradication - a Multicenter Randomized Parallel Controlled Study
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
NOT_YET_RECRUITING
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:
Helicobacter pylori infection is closely related to gastritis peptic ulcer mucosa-associated lymphoid tissue lymphoma and gastric cancer Eradication of HP can significantly improve and reduce HP-related diseases International and domestic guidelines recommend a 10-14 day quadruple regimen containing bismuth as first-line treatment achieving an eradication rate of more than 80 However some disadvantages of these quadruple regimens such as severe adverse reactions high medical costs and low compliance prevent their application in clinical practice Studies at home and abroad have shown that high-dose proton pump inhibitors combined with amoxicillin can be used as the first-line treatment for HP eradication with good efficacy and compliance and low rate of adverse reactions And because it is a single antibiotic therapy we do not expect this regimen to increase antibiotic resistance rates for HP The maintenance of gastric PH 6 is one of the key factors for HP eradication The acid inhibition effect of proton pump mainly depends on the degree of individual metabolism of proton pump Vonoprazan fumarate a new competitive potassium acid blocker is not affected by gene polymorphism and has the advantage of stronger and longer inhibition effect on gastric acid compared with proton pump inhibitors In most parts of China HP is characterized by high infection rate and antibiotic resistance rate requiring higher eradication rate and safety regimen This study compared the efficacy and safety of vonoprazan fumarate combined with amoxicillin and bismuth-containing quadruple regimen in first-line HP eradication in order to find a more suitable regimen for HP eradication
Detailed Description:
None
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