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Recruiting 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

Phase IV Interventional the Eradication Rates of Helicobacter Pylori

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rabeprazloe+bismuth+amoxicillin+clarithromycin, Vonoprazan+amoxicillin+clarithromycin 14 days, Vonoprazan+amoxicillin+clarithromycin 7 days, Vonoprazan+tetracycline+furazolidone 14 days.
Who it may be relevant to
Registry conditions: the Eradication Rates of Helicobacter Pylori. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Eradication rate of Helicobacter pylori [Time frame: Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment]
Secondary outcome measures (3)
  • Incidence of adverse effects [Time frame: 14 days of treatment, and 28 days after treatment]
  • Treatment compliance [Time frame: 7 or 14 days of treatment]
  • Symptom relief rate [Time frame: 14 days of treatment, and 28 days after treatment]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Ying han — Xi'an

Identifiers

NCT: NCT06168214 · XJLL-KY-20230499

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗