Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori:a Prospective, Multicenter, Open Label, Randomized Controlled Study:

KY20221124-07

The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.

2023-01-20

2024-12-01

2024-12-01

Recruiting

Early phase I

900

Inclusion Criteria: 1. Ages between 18 and 70 years; Sexes eligible for study: both; 2. patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test; 3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months; 4. voluntary to be involved in the study and written informed consent was obtained from all patients Exclusion Criteria: 1. allergic reactions to the study drugs; 2. patients with peptic ulcer; 3. patients who underwent eradication therapy for Helicobacter pylori during the last six months; 4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment; 5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants; 6. patients who have history of esophageal or gastric surgery; 7. pregnant or lactating women; 8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies; 9. Alcohol abusers 10. MALT lymphoma of stomach or malignant tumor

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 900, 'type': 'ESTIMATED'}}

2024-05-29