Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

Nanjing Medical University

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Amoxicillin; Drug: Vonoprazan

Study type: Interventional

Funder types: Other

Identifiers

NCT05649540

KY20221124-07

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.

Full description

This study intends to select the patients with Hp infection in 13 tertiary hospitals across our country, and randomly give the three therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with H.pylori infection.

Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.

Enrollment: 900 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ages between 18 and 70 years; Sexes eligible for study: both;
2. patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test;
3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
4. voluntary to be involved in the study and written informed consent was obtained from all patients

Exclusion criteria

1. allergic reactions to the study drugs;
2. patients with peptic ulcer;
3. patients who underwent eradication therapy for Helicobacter pylori during the last six months;
4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
6. patients who have history of esophageal or gastric surgery;
7. pregnant or lactating women;
8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
9. Alcohol abusers
10. MALT lymphoma of stomach or malignant tumor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 3 patient groups

high dose amoxicillin with vonoprazan group

Active Comparator group

Description:

vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days

Treatment:

Drug: Vonoprazan

Drug: Amoxicillin

standard dose amoxicillin with vonoprazan group

Experimental group

Description:

vonoprazan 20mg bid and amoxicillin 1000mg bid for 14 days

Treatment:

Drug: Vonoprazan

Drug: Amoxicillin

low dose amoxicillin with vonoprazan group

Experimental group

Description:

vonoprazan 20mg bid and amoxicillin 500mg tid for 14 days

Treatment:

Drug: Vonoprazan

Drug: Amoxicillin