NCT06168214

Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication

Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication: A Single-center, Randomised, Controlled Trial.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,404 (estimated)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are: * Main indicators: the eradication rate of Helicobacter pylori for eradication. * Secondary indicators: symptomatic relief rate at 2 weeks after treatment and 4 weeks after the end of treatment; compliance and adverse reactions during treatment.

Conditions

• the Eradication Rates of Helicobacter Pylori

Interventions

Type	Name	Description
DRUG	Rabeprazloe+bismuth+amoxicillin+clarithromycin	PBAC: 14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
DRUG	Vonoprazan+amoxicillin+clarithromycin 14 days	VAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
DRUG	Vonoprazan+amoxicillin+clarithromycin 7 days	VAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
DRUG	Vonoprazan+tetracycline+furazolidone 14 days	VTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
DRUG	Vonoprazan+tetracycline+furazolidone 7 days	VTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
DRUG	Vonoprazan+amoxicillin+furazolidone 7 days	hVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid.
DRUG	Vonoprazan+amoxicillin+tetracycline 14 days	hVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid.
DRUG	Vonoprazan+amoxicillin 7 days	hVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.
DRUG	Vonoprazan+amoxicillin 14 days	hVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.

Timeline

• Start date: 2023-09-04
• Primary completion: 2024-11-25
• Completion: 2024-12-25
• First posted: 2023-12-13
• Last updated: 2024-08-13

Locations

1 site across 1 country: China