Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06037122
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-14
First Post:
2023-09-07
Brief Title:
Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Efficacy and Safety Evaluation of Bismuth-containing Quadruple Therapies Based on Low-dose Vonoprazan in the Initial Treatment of Helicobacter Pylori Infection a Retrospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
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:
The primary objective of this retrospective study was to assess the efficacy and safety of a bismuth quadruple regimen of a low-dose potassium-competitive acid blocker versus a standard-dose potassium-competitive acid blocker and a standard-dose proton pump inhibitor combined with amoxicillin and clarithromycin as the initial treatment of Helicobacter pylori infection
Detailed Description:
Helicobacter pylori H pylori infection is closely associated with a variety of diseases including chronic gastritis peptic ulcer and gastric cancer Adequate acid suppression is essential for H pylori eradication therapy Potassium-competitive acid blocker P-CAB vonoprazan VPZ has faster stronger and longer-lasting acid inhibition and plays an important role in H pylori treatment 2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment recommended for the first time a quadruple regimen of bismuth containing P-CAB for H pylori eradication in which P-CAB was administered as VPZ 20 mg twice daily In this retrospective study we compared the efficacy and safety of a quadruple regimen based on low-dose P-CAB VPZ 20 mg once daily versus a quadruple regimen based on standard-dose P-CAB VPZ 20 mg twice daily or standard-dose proton pump inhibitor rabeprazole 10 mg twice daily containing amoxicillin clarithromycin and bismuth as initial treatment for H pylori infection Our study will provide clinical evidence for the necessary dosage of VPZ in bismuth quadruple regimens which will help to further optimize the treatment regimen for H pylori infection
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