Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05719831
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2023-01-31
Brief Title:
Optimization of Vonoprazan--amoxicillin Dual Therapy for Eradicating Helicobacter Pyloriinfection
Sponsor:
Sixth Affiliated Hospital Sun Yat-sen University
Organization:
Sixth Affiliated Hospital Sun Yat-sen University
Study Overview
Official Title:
Optimization of Vonoprazan--amoxicillin Dual Therapy for Eradicating Helicobacter pyloriinfection-a Multicenter Prospective Randomized Parallel-controlled Study
Status:
COMPLETED
Status Verified Date:
2023-10
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:
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 regimenThis study aimed to evaluate two different amoxicillin dosages
1 g bid vs 075 g qid and two different durations of therapy 14 vs10 days to gain insights of the effectiveness of VA dual therapy
1 g bid vs 075 g qid and two different durations of therapy 14 vs10 days to gain insights of the effectiveness of VA dual therapy
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