Clinical trial NCT04907747: Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication
Official title: Efficacy and Safety of Furazolidone-based Quadruple Therapy With Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
vonoprazan
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Helicobacter pylori Eradication Rate
timeFrame: Six to eight weeks after completion of the medication
Secondary outcomes:
measure: Rate of Adverse Drug Reaction(ADR)
timeFrame: Within 7 days after completion of therapy
measure: Compliance Rate
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University, School of Medicine
state: Zhejiang
Study officials:
References: