Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication

Nanjing Medical University

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Vonoprazan; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT05469685

KY20220701-06

Details and patient eligibility

About

The purpose of this study was to evaluate the Efficacy and Safety of Vonoprazan- amoxicillin dual therapy for Helicobacter Pylori eradication

Full description

This study intends to select the patients with Hp infection in 11 tertiary hospitals across our country, and randomly give the two 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: 914 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ages between 18 and 65 years; Sexes eligible for study: both;
2. patients who are diagnosed with Helicobacter pylori;
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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914 participants in 2 patient groups

10-day treatment group

Experimental group

Description:

vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days

Treatment:

Drug: Amoxicillin

Drug: Vonoprazan

14-day treatment group

Active Comparator group

Description:

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

Treatment:

Drug: Amoxicillin

Drug: Vonoprazan