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

Xijing Hospital of Digestive Diseases

Status and phase: Enrolling; Phase 4

Conditions: the Eradication Rates of Helicobacter Pylori

Treatments: Drug: Vonoprazan+amoxicillin+clarithromycin 14 days; Drug: Vonoprazan+tetracycline+furazolidone 14 days; Drug: Vonoprazan+amoxicillin 14 days; Drug: Rabeprazloe+bismuth+amoxicillin+clarithromycin; Drug: Vonoprazan+amoxicillin+clarithromycin 7 days; Drug: Vonoprazan+amoxicillin 7 days; Drug: Vonoprazan+tetracycline+furazolidone 7 days; Drug: Vonoprazan+amoxicillin+furazolidone 7 days; Drug: Vonoprazan+amoxicillin+tetracycline 14 days

Study type: Interventional

Funder types: Other

Identifiers

NCT06168214

XJLL-KY-20230499

Details and patient eligibility

About

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.

Enrollment: 1,404 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,404 participants in 9 patient groups

Rabeprazloe+bismuth+amoxicillin+clarithromycin 14days

Active Comparator group

Description:

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.

Treatment:

Drug: Rabeprazloe+bismuth+amoxicillin+clarithromycin

Vonoprazan+amoxicillin+clarithromycin 14 days

Experimental group

Description:

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

Treatment:

Drug: Vonoprazan+amoxicillin+clarithromycin 14 days

Vonoprazan+amoxicillin+clarithromycin 7 days

Experimental group

Description:

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

Treatment:

Drug: Vonoprazan+amoxicillin+clarithromycin 7 days

Vonoprazan+tetracycline+furazolidone 14 days

Experimental group

Description:

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

Treatment:

Drug: Vonoprazan+tetracycline+furazolidone 14 days

Vonoprazan+tetracycline+furazolidone 7 days

Experimental group

Description:

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

Treatment:

Drug: Vonoprazan+tetracycline+furazolidone 7 days

Vonoprazan+amoxicillin+furazolidone 7 days

Experimental group

Description:

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

Treatment:

Drug: Vonoprazan+amoxicillin+furazolidone 7 days

Vonoprazan+amoxicillin+tetracycline 14 days

Experimental group

Description:

7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; T: tetracycline 500mg tid.

Treatment:

Drug: Vonoprazan+amoxicillin+tetracycline 14 days

Vonoprazan+amoxicillin 7 days

Experimental group

Description:

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

Treatment:

Drug: Vonoprazan+amoxicillin 7 days

Vonoprazan+amoxicillin 14 days

Experimental group

Description:

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

Treatment:

Drug: Vonoprazan+amoxicillin 14 days