Ten-day Amoxicillin-containing Dual Therapy as First-line Helicobacter Pylori Treatment in Elderly Patients: a Randomized Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 393
- 试验地点
- 1
- 主要终点
- Helicobacter pylori Eradication Rate
研究概览
简要总结
This study aims to evaluate the efficacy of dual therapy compared with bismuth-containing quadruple therapy as first-line treatment for Helicobacter Pylori eradication, as well as the safety and economic benefits.
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having H. pylori related chronic gastritis confirmed by ¹³C-urea breath test, ¹⁴C-urea breath test and/or biopsy；
- •underwent gastroscopy within 1 year before treatment, liver and renal function tests and electrocardiogram within 3 months before treatment；
- •with no historical treatment for helicobacter pylori infection.
排除标准
- •administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion
- •with previous esophageal or gastric surgery
- •with severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases
- •allergy to any of the study drugs
- •participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher
研究组 & 干预措施
groupA: dual therapy (vonoprazan+amoxicillin)
vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days
干预措施: Vonoprazan (Drug)
groupA: dual therapy (vonoprazan+amoxicillin)
vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days
干预措施: Amoxicillin (Drug)
group B: dual therapy (rabeprazole+amoxicillin)
rabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days
干预措施: Rabeprazole (Drug)
group B: dual therapy (rabeprazole+amoxicillin)
rabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days
干预措施: Amoxicillin (Drug)
group C: bismuth-containing quadruple therapy
rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days
干预措施: Rabeprazole (Drug)
group C: bismuth-containing quadruple therapy
rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days
干预措施: Amoxicillin (Drug)
group C: bismuth-containing quadruple therapy
rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days
干预措施: Clarithromycin (Drug)
group C: bismuth-containing quadruple therapy
rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days
干预措施: Colloidal bismuth pectin (Drug)
结局指标
主要结局
Helicobacter pylori Eradication Rate
时间窗: Six to eight weeks after completion of the medication
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test six to eight 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
- Rate of Adverse Drug Reaction(ADR)(Within 7 days after completion of therapy)
- Compliance Rate(Within 7 days after completion of therapy)