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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04907747

Collaborator

(none)

234

Enrollment

Location

Arms

10.8

Anticipated Duration (Months)

21.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Vonoprazan Drug: Esomeprazole Drug: Colloidal bismuth pectin Drug: Amoxicillin Drug: Furazolidone	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

234 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 18, 2021

Anticipated Primary Completion Date :

Apr 13, 2022

Anticipated Study Completion Date :

Apr 13, 2022

Arms and Interventions

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: Vonoprazan Potassium-competitive acid blocker Drug: Colloidal bismuth pectin Gastric mucosal protective drug with anti-H. pylori effect Drug: Amoxicillin Antibiotic for H. pylori eradication 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: Vonoprazan Potassium-competitive acid blocker Drug: Colloidal bismuth pectin Gastric mucosal protective drug with anti-H. pylori effect Drug: Amoxicillin Antibiotic for H. pylori eradication 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: Colloidal bismuth pectin Gastric mucosal protective drug with anti-H. pylori effect Drug: Amoxicillin Antibiotic for H. pylori eradication Drug: Furazolidone Antibiotic for H. pylori eradication

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: Vonoprazan

Potassium-competitive acid blocker

Drug: Colloidal bismuth pectin

Gastric mucosal protective drug with anti-H. pylori effect

Drug: Amoxicillin

Antibiotic for H. pylori eradication

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: Vonoprazan

Potassium-competitive acid blocker

Drug: Colloidal bismuth pectin

Gastric mucosal protective drug with anti-H. pylori effect

Drug: Amoxicillin

Antibiotic for H. pylori eradication

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: Colloidal bismuth pectin

Gastric mucosal protective drug with anti-H. pylori effect

Drug: Amoxicillin

Antibiotic for H. pylori eradication

Drug: Furazolidone

Antibiotic for H. pylori eradication

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Adverse Drug Reaction(ADR) [Within 7 days after completion of therapy]
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).
Compliance Rate [Within 7 days after completion of therapy]
Compliance was defined as poor when they had taken less than 80% of the total medication.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
Active peptic ulcer with complications such as hemorrhage, perforation, obstruction, cancerization, etc.
With previous esophageal or gastric surgery
With severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases
Allergy to any of the study drugs
Pregnancy or in lactation
Participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher