Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication
NCT ID: NCT04907747
Last Updated: 2021-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
234 participants
INTERVENTIONAL
2021-05-18
2022-04-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vonoprazan Hp Dual or Triple Eradication Regimes
NCT05345210
A RCT of the Efficacy of Vonoprazan 20mg QD in the Treatment of Helicobacter Pylori Infection
NCT05590286
Efficacy of Vonoprazan in Eradication of Resistant Strain of Helicobacter Pylori
NCT06414707
Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication
NCT06168214
Vonoprazan in Helicobacter Pylori Treatment an RCT
NCT04901663
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Vonoprazan
Potassium-competitive acid blocker
Colloidal bismuth pectin
Gastric mucosal protective drug with anti-H. pylori effect
Amoxicillin
Antibiotic for H. pylori eradication
Furazolidone
Antibiotic for H. pylori eradication
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
Vonoprazan
Potassium-competitive acid blocker
Colloidal bismuth pectin
Gastric mucosal protective drug with anti-H. pylori effect
Amoxicillin
Antibiotic for H. pylori eradication
Furazolidone
Antibiotic for H. pylori eradication
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
Esomeprazole
Proton pump inhibitor
Colloidal bismuth pectin
Gastric mucosal protective drug with anti-H. pylori effect
Amoxicillin
Antibiotic for H. pylori eradication
Furazolidone
Antibiotic for H. pylori eradication
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vonoprazan
Potassium-competitive acid blocker
Esomeprazole
Proton pump inhibitor
Colloidal bismuth pectin
Gastric mucosal protective drug with anti-H. pylori effect
Amoxicillin
Antibiotic for H. pylori eradication
Furazolidone
Antibiotic for H. pylori eradication
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. With no historical treatment for helicobacter pylori infection.
Exclusion Criteria
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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Lu L, Wang Y, Ye J, Han Y, Lou G, Li Y, Yan H, Du Q. Quadruple therapy with vonoprazan 20 mg daily as a first-line treatment for Helicobacter pylori infection: A single-center, open-label, noninferiority, randomized controlled trial. Helicobacter. 2023 Feb;28(1):e12940. doi: 10.1111/hel.12940. Epub 2022 Dec 1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-0446
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.