Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication

Zhejiang University

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Vonoprazan; Drug: Colloidal bismuth pectin; Drug: Esomeprazole; Drug: Furazolidone; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT04907747

2021-0446

Details and patient eligibility

About

This study aims to evaluate the efficacy of vonoprazan compared with esomeprazole as first-line treatment for Helicobacter Pylori(Hp) eradication, as well as the safety and economic benefits.

Full description

Vonoprazan, a novel potassium-competitive acid blocker, is proved to be superior to proton pump inhibitor in gastric acid-related diseases such as reflux esophagitis, as the increase of intragastric pH maintains for a longer period. Vonoprazan, therefore, is a promising candidate in helicobacter pylori eradication as the antibiotic resistance is rising.

This study will enroll 234 patients, and randomly assigned by computer to one of the three treatment groups.

Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days Participants will visit the clinic for a follow-up assessment 6-8 weeks after the course of treatments.

Enrollment: 234 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Helicobacter pylori-positive participants determined by ¹³C-urea breath test, ¹⁴C-urea breath test, HE stain or bacterium culture
2. With no historical treatment for helicobacter pylori infection.

Exclusion criteria

1. Administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion
2. Active peptic ulcer with complications such as hemorrhage, perforation, obstruction, cancerization, etc.
3. With previous esophageal or gastric surgery
4. With severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases
5. Allergy to any of the study drugs
6. Pregnancy or in lactation
7. Participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 3 patient groups

Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days

Experimental group

Description:

Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 10days

Treatment:

Drug: Vonoprazan

Drug: Amoxicillin

Drug: Colloidal bismuth pectin

Drug: Furazolidone

Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days

Experimental group

Description:

Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days

Treatment:

Drug: Vonoprazan

Drug: Amoxicillin

Drug: Colloidal bismuth pectin

Drug: Furazolidone

Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days

Active Comparator group

Description:

Esomeprazole 20 mg bid, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days

Treatment:

Drug: Amoxicillin

Drug: Colloidal bismuth pectin

Drug: Esomeprazole

Drug: Furazolidone