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

Efficacy and Safety of Furazolidone-based Quadruple Therapy With Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication: A Prospective Randomized Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Esomeprazole; Drug: Amoxicillin; Drug: Vonoprazan; Drug: Colloidal bismuth pectin; Drug: Furazolidone

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 234
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital of Zhejiang University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days; Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 10days	Drug: Amoxicillin; Antibiotic for H. pylori eradication; Drug: Vonoprazan; Potassium-competitive acid blocker; Drug: Colloidal bismuth pectin; Gastric mucosal protective drug with anti-H. pylori effect; Drug: Furazolidone; Antibiotic for H. pylori eradication
Experimental: Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days; Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days	Drug: Amoxicillin; Antibiotic for H. pylori eradication; Drug: Vonoprazan; Potassium-competitive acid blocker; Drug: Colloidal bismuth pectin; Gastric mucosal protective drug with anti-H. pylori effect; Drug: Furazolidone; Antibiotic for H. pylori eradication
Active Comparator: Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days; Esomeprazole 20 mg bid, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days	Drug: Esomeprazole; Proton pump inhibitor; Drug: Amoxicillin; Antibiotic for H. pylori eradication; Drug: Colloidal bismuth pectin; Gastric mucosal protective drug with anti-H. pylori effect; Drug: Furazolidone; Antibiotic for H. pylori eradication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori Eradication Rate	Helicobacter pylori Eradication will be determined by ¹³C-urea breath test six to eight weeks after completion of the medication.	Six to eight weeks after completion of the medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Within 7 days after completion of therapy

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 18, 2021
• Primary Completion (Anticipated): April 13, 2022
• Study Completion (Anticipated): April 13, 2022

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Helicobacter pylori; vonoprazan
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Monoamine Oxidase Inhibitors; Antacids; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Amoxicillin; Esomeprazole; Bismuth; Furazolidone
• Other Study ID Numbers: 2021-0446

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No