Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori:a Prospective, Multicenter, Open Label, Randomized Controlled Study:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 13
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.
详细描述
This study intends to select the patients with Hp infection in 13 tertiary hospitals across our country, and randomly give the three therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with H.pylori infection.
Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.
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
- None
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
- 否
入选标准
- •Ages between 18 and 70 years; Sexes eligible for study: both;
- •patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test;
- •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;
- •voluntary to be involved in the study and written informed consent was obtained from all patients
排除标准
- •allergic reactions to the study drugs;
- •patients with peptic ulcer;
- •patients who underwent eradication therapy for Helicobacter pylori during the last six months;
- •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;
- •patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
- •patients who have history of esophageal or gastric surgery;
- •pregnant or lactating women;
- •patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
- •Alcohol abusers
- •MALT lymphoma of stomach or malignant tumor
研究组 & 干预措施
high dose amoxicillin with vonoprazan group
vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
干预措施: Vonoprazan (Drug)
high dose amoxicillin with vonoprazan group
vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
干预措施: Amoxicillin (Drug)
standard dose amoxicillin with vonoprazan group
vonoprazan 20mg bid and amoxicillin 1000mg bid for 14 days
干预措施: Vonoprazan (Drug)
standard dose amoxicillin with vonoprazan group
vonoprazan 20mg bid and amoxicillin 1000mg bid for 14 days
干预措施: Amoxicillin (Drug)
low dose amoxicillin with vonoprazan group
vonoprazan 20mg bid and amoxicillin 500mg tid for 14 days
干预措施: Vonoprazan (Drug)
low dose amoxicillin with vonoprazan group
vonoprazan 20mg bid and amoxicillin 500mg tid for 14 days
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: four to eight weeks after completion of the medication
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
次要结局
- Microbiota influence(baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy)
- Adverse event(Within 7 days after completion of therapy)
- Compliance Rate(Within 7 days after completion of therapy)
研究者
Zhenyu Zhang
Director of Gastroenterology
Nanjing First Hospital, Nanjing Medical University