Efficacy and safety of dual therapy containing vonopranzan and amoxicillin as first line Helicobacter pylori eradication: a randomized, non-inferiority trial
Phase 2
- Conditions
- Helicobacter pylori infection
- Registration Number
- JPRN-UMIN000034140
- Lead Sponsor
- Division of Gastroenterology and Hepatology, Department of Medicine,Nihon University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 335
Inclusion Criteria
Not provided
Exclusion Criteria
1) Allergy to vonoprazan, amoxicillin, or clarithromycin 2) A history of receiving H. pylori eradication therapy 3) A history of gastric surgery 4) Using PPI 5) Using antibiotics 6) Using steroid 7) Pregnancy 8) Breast-feeding 9) Lack of informed consent 10) Others
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this study is H. pylori eradication rates in the dual therapy and the standard triple therapy groups. Eradication success is evaluated at least 4 weeks after the treatment period using the urea breath test with success defined as a result of < 2.5 permil.
- Secondary Outcome Measures
Name Time Method 1. The rate of adverse events 2. The rate of treatment or intervention for adverse events 3. Number of defecation 4. Stool forms 5. Compliance of taking drugs 6. Eradication rate in patients who have H. pylori with antibiotic resistance 7. Oral and gut microbiota proliferation