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 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1404
Last updated 2024-08-13
Summary
The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are:
* Main indicators: the eradication rate of Helicobacter pylori for eradication.
* Secondary indicators: symptomatic relief rate at 2 weeks after treatment and 4 weeks after the end of treatment; compliance and adverse reactions during treatment.
Conditions
- the Eradication Rates of Helicobacter Pylori
Interventions
- DRUG
-
Rabeprazloe+bismuth+amoxicillin+clarithromycin
PBAC: 14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
- DRUG
-
Vonoprazan+amoxicillin+clarithromycin 14 days
VAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
- DRUG
-
Vonoprazan+amoxicillin+clarithromycin 7 days
VAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
- DRUG
-
Vonoprazan+tetracycline+furazolidone 14 days
VTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
- DRUG
-
Vonoprazan+tetracycline+furazolidone 7 days
VTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
- DRUG
-
Vonoprazan+amoxicillin+furazolidone 7 days
hVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid.
- DRUG
-
Vonoprazan+amoxicillin+tetracycline 14 days
hVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid.
- DRUG
-
Vonoprazan+amoxicillin 7 days
hVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.
- DRUG
-
Vonoprazan+amoxicillin 14 days
hVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.
Sponsors & Collaborators
-
Xijing Hospital of Digestive Diseases
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-09-04
- Primary Completion
- 2024-11-25
- Completion
- 2024-12-25
Countries
- China
Study Locations
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