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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXijing Hospital of Digestive Diseases

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rabeprazloe+bismuth+amoxicillin+clarithromycin

    Drug

    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.

  • Vonoprazan+amoxicillin+clarithromycin 14 days

    Drug

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

  • Vonoprazan+amoxicillin+clarithromycin 7 days

    Drug

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

  • Vonoprazan+tetracycline+furazolidone 14 days

    Drug

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

  • Vonoprazan+tetracycline+furazolidone 7 days

    Drug

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

  • Vonoprazan+amoxicillin+furazolidone 7 days

    Drug

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

  • Vonoprazan+amoxicillin+tetracycline 14 days

    Drug

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

  • Vonoprazan+amoxicillin 7 days

    Drug

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

  • Vonoprazan+amoxicillin 14 days

    Drug

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

Treatment groups

1,404 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Rabeprazloe+bismuth+amoxicillin+clarithromycin 14daysActive comparator 1 intervention
Group B: Vonoprazan+amoxicillin+clarithromycin 14 daysExperimental treatment 1 intervention
Group C: Vonoprazan+amoxicillin+clarithromycin 7 daysExperimental treatment 1 intervention
Group D: Vonoprazan+tetracycline+furazolidone 14 daysExperimental treatment 1 intervention
Group E: Vonoprazan+tetracycline+furazolidone 7 daysExperimental treatment 1 intervention
Group F: Vonoprazan+amoxicillin+furazolidone 7 daysExperimental treatment 1 intervention
Group G: Vonoprazan+amoxicillin+tetracycline 14 daysExperimental treatment 1 intervention
Group H: Vonoprazan+amoxicillin 7 daysExperimental treatment 1 intervention
Group I: Vonoprazan+amoxicillin 14 daysExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Eradication rate of Helicobacter pylori

Evaluated by 13C/14C-urea Breath test results and/or monoclonal faecal antigen test results were assessed as negative for successful eradication and positive for negative for successful eradication, positive for failed eradication 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication and positive for (assessed by 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication, positive for failure).

Time frame
Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment

Secondary outcomes

1

Incidence of adverse effects

According to the requirements of the "Drug Clinical Trial Management Code", the observation is carried out, and the adverse reactions of the patients during the administration of the drug are recorded. The severity, or intensity, of an AE refers to the extent to which an AE affects the subject' s daily activities. The intensity of the AE will be rated as mild (discomfort without influencing daily activities), moderate (discomfort partially influencing daily activities), or severe (discomfort with severe interruption with daily activities).

Time frame
14 days of treatment, and 28 days after treatment
2

Treatment compliance

Adherence was analysed according to medication possession ratio (MPR), where taking less than 80% of study drug during any evaluation period or failure to review was considered poor adherence;

Time frame
7 or 14 days of treatment
3

Symptom relief rate

Patients were classified as no change, remission, cure, or exacerbation based on changes in clinical symptoms.

Time frame
14 days of treatment, and 28 days after treatment

Other outcomes

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