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

Second Affiliated Hospital, School of Medicine, Zhejiang University234 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

234

Conditions

Helicobacter Pylori Infection

Interventions

VonoprazanDRUG

Potassium-competitive acid blocker

EsomeprazoleDRUG

Proton pump inhibitor

Colloidal bismuth pectinDRUG

Gastric mucosal protective drug with anti-H. pylori effect

Amoxicillin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Helicobacter pylori Eradication Rate

Helicobacter pylori Eradication will be determined by ¹³C-urea breath test six to eight weeks after completion of the medication.

Time frame: Six to eight weeks after completion of the medication

Secondary Outcomes

Rate of Adverse Drug Reaction(ADR)

Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure).

Time frame: Within 7 days after completion of therapy

Compliance Rate

Compliance was defined as poor when they had taken less than 80% of the total medication.

Time frame: Within 7 days after completion of therapy

Central Contacts

Qin Du, Master

CONTACT

+86 0571-89713734 duq518@163.com

Data from ClinicalTrials.gov

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