Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, vonoprazan
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.
Interventions
DRUGVonoprazan
Potassium-competitive acid blocker
DRUGEsomeprazole
Proton pump inhibitor
Gastric mucosal protective drug with anti-H. pylori effect
DRUGAmoxicillin
Antibiotic for H. pylori eradication
DRUGFurazolidone
Antibiotic for H. pylori eradication
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactQin Du, Master
Outcome results
None listed