Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT04907747
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 234
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days Amoxicillin Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 10days Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days Colloidal bismuth pectin Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 10days Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days Colloidal bismuth pectin Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days Colloidal bismuth pectin Esomeprazole 20 mg bid, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days Vonoprazan Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 10days Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days Furazolidone Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 10days Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days Vonoprazan Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days Amoxicillin Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days Furazolidone Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days Esomeprazole Esomeprazole 20 mg bid, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days Furazolidone Esomeprazole 20 mg bid, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days Amoxicillin Esomeprazole 20 mg bid, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Second Affiliated Hospital of Zhejiang University, School of Medicine
🇨🇳Hangzhou, Zhejiang, China