RecruitingPhase 4NCT06168214

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.


Sponsor

Xijing Hospital of Digestive Diseases

Enrollment

1,404 participants

Start Date

Sep 4, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

  • Age 18-70 years, regardless of sex; chronic gastritis, peptic ulcer or dyspeptic symptoms, clear Hp infection (positive 13C-urea breath test); voluntary Hp eradication treatment; women of childbearing age are required to use a medically desirable form of contraception during the trial and for 1 month after the trial.

Exclusion Criteria1

  • Have contraindications to the study drug or are allergic to the study drug; have taken a PPI within 2 weeks and an antibiotic or bismuth within 4 weeks; pregnant and lactating women; and Have undergone upper gastrointestinal surgery; refluse to sign the informed consent document.

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Interventions

DRUGRabeprazloe+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.

DRUGVonoprazan+amoxicillin+clarithromycin 14 days

VAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.

DRUGVonoprazan+amoxicillin+clarithromycin 7 days

VAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.

DRUGVonoprazan+tetracycline+furazolidone 14 days

VTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.

DRUGVonoprazan+tetracycline+furazolidone 7 days

VTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.

DRUGVonoprazan+amoxicillin+furazolidone 7 days

hVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid.

DRUGVonoprazan+amoxicillin+tetracycline 14 days

hVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid.

DRUGVonoprazan+amoxicillin 7 days

hVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.

DRUGVonoprazan+amoxicillin 14 days

hVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.


Locations(1)

Ying han

Xi'an, Shaanxi, China

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NCT06168214