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.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,404
- 试验地点
- 1
- 主要终点
- Eradication rate of Helicobacter pylori
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Vonoprazan+amoxicillin+tetracycline 14 days
7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; T: tetracycline 500mg tid.
干预措施: Vonoprazan+amoxicillin+tetracycline 14 days (Drug)
Rabeprazloe+bismuth+amoxicillin+clarithromycin 14days
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.
干预措施: Rabeprazloe+bismuth+amoxicillin+clarithromycin (Drug)
Vonoprazan+amoxicillin+clarithromycin 14 days
14D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
干预措施: Vonoprazan+amoxicillin+clarithromycin 14 days (Drug)
Vonoprazan+amoxicillin+clarithromycin 7 days
7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
干预措施: Vonoprazan+amoxicillin+clarithromycin 7 days (Drug)
Vonoprazan+tetracycline+furazolidone 14 days
14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
干预措施: Vonoprazan+tetracycline+furazolidone 14 days (Drug)
Vonoprazan+tetracycline+furazolidone 7 days
7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
干预措施: Vonoprazan+tetracycline+furazolidone 7 days (Drug)
Vonoprazan+amoxicillin+furazolidone 7 days
7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; F: furazolidone 100mg bid.
干预措施: Vonoprazan+amoxicillin+furazolidone 7 days (Drug)
Vonoprazan+amoxicillin 7 days
7D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid.
干预措施: Vonoprazan+amoxicillin 7 days (Drug)
Vonoprazan+amoxicillin 14 days
14D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid.
干预措施: Vonoprazan+amoxicillin 14 days (Drug)
结局指标
主要结局
Eradication rate of Helicobacter pylori
时间窗: Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment
Evaluated by 13C/14C-urea Breath test results and/or monoclonal faecal antigen test results were assessed as negative for successful eradication and positive for negative for successful eradication, positive for failed eradication 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication and positive for (assessed by 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication, positive for failure).
次要结局
- Treatment compliance(7 or 14 days of treatment)
- Incidence of adverse effects(14 days of treatment, and 28 days after treatment)
- Symptom relief rate(14 days of treatment, and 28 days after treatment)
研究者
Han Ying
Prof
Xijing Hospital of Digestive Diseases