Clinical trial
Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication: A Single-center, Randomised, Controlled Trial.
Name
XJLL-KY-20230499
Description
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: 4-6 weeks after the end of treatment, 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.
Trial arms
Trial start
2023-09-04
Estimated PCD
2024-06-25
Trial end
2024-06-25
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Rabeprazloe+bismuth+amoxicillin+clarithromycin 14days
Vonoprazan+amoxicillin+clarithromycin 14 days
VAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Arms:
Vonoprazan+amoxicillin+clarithromycin 14 days
Vonoprazan+amoxicillin+clarithromycin 7 days
VAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Arms:
Vonoprazan+amoxicillin+clarithromycin 7 days
Vonoprazan+tetracycline+furazolidone 14 days
VTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
Arms:
Vonoprazan+tetracycline+furazolidone 14 days
Vonoprazan+tetracycline+furazolidone 7 days
VTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
Arms:
Vonoprazan+tetracycline+furazolidone 7 days
Vonoprazan+amoxicillin+furazolidone 7 days
hVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid.
Arms:
Vonoprazan+amoxicillin+furazolidone 7 days
Vonoprazan+amoxicillin+tetracycline 14 days
hVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid.
Arms:
Vonoprazan+amoxicillin+tetracycline 14 days
Vonoprazan+amoxicillin 7 days
hVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.
Arms:
Vonoprazan+amoxicillin 7 days
Vonoprazan+amoxicillin 14 days
hVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.
Arms:
Vonoprazan+amoxicillin 14 days
Size
1404
Primary endpoint
Eradication rate of Helicobacter pylori
Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment
Eligibility criteria
Inclusion Criteria:
* Age 18-70 years, regardless of sex; chronic gastritis, peptic ulcer or dyspeptic symptoms, clear Hp infection (positive 13C-urea breath test); voluntary Hp eradication treatment; women of childbearing age are required to use a medically desirable form of contraception during the trial and for 1 month after the trial.
Exclusion Criteria:
* Have contraindications to the study drug or are allergic to the study drug; have taken a PPI within 2 weeks and an antibiotic or bismuth within 4 weeks; pregnant and lactating women; and Have undergone upper gastrointestinal surgery; refluse to sign the informed consent document.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 1404, 'type': 'ESTIMATED'}}
Updated at
2023-12-19
1 organization
7 products
1 indication
Organization
Xijing Hospital of Digestive DiseasesIndication
Eradication Rates of Helicobacter PyloriProduct
VonoprazanProduct
Vonoprazan + Amoxicillin