NCT01607918Unknown4 期
Comparison of the Efficacy of Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy for 10 Days in the First Line Therapy for Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 1,300
- 试验地点
- 2
- 主要终点
- Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
研究概览
简要总结
The investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrollment.
- •Written informed consents will be obtained from all patients prior to enrollment.
排除标准
- •Patients will be excluded from the study if any one of the following criteria is present:
- •children and teenagers aged less than 20 years,
- •history of gastrectomy,
- •gastric malignancy, including adenocarcinoma and lymphoma,
- •previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole), - contraindication to treatment drugs,
- •pregnant or lactating women,
- •severe concurrent disease
- •Patients who cannot give informed consent by himself or herself.
结局指标
主要结局
Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
时间窗: 6 weeks
C13-UBT will be used to assess the existence of H. pylori
次要结局
- Incidence of adverse effects(during eradication therapy)
研究者
National Taiwan University Hospital
Doctor and Principle Investigator, Department of Gastroenterology
National Taiwan University Hospital
研究点 (2)
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