NCT02776371已完成4 期
Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori
Shandong University1 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- the difference of eradication rates between 2 groups
研究概览
简要总结
Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1), especially 47-66% in China.
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
- 是
入选标准
- •Patients who were intend to undergo upper endoscopy for any purpose and volunteered to written inform consent.
排除标准
- •negative in rapid urease test (RUT)
- •previous standard eradication therapy for H. pylori;
- •history of esophagectomy or gastrectomy;
- •gastrointestinal malignancy;
- •contraindications or allergic to study drugs;
- •user of taking medicine that may affect the result of the study within 4 weeks (e.g., proton-pump inhibitors, H2-receptor antagonists, bismuth or antibiotics etc.);
- •cardiopulmonary, hepatic or renal insufficiency, and/or severe current diseases or malignancy;
- •pregnant or lactating women;
- •participants of other trial within the past 3 months;
- •unwilling or unable to participate in the study.
研究组 & 干预措施
Modified non-clarithromycin triple therapy
Experimental
H.pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.
干预措施: Modified non-clarithromycin triple therapy (Drug)
Sequential therapy
Active Comparator
H.pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.
干预措施: Sequential therapy (Drug)
结局指标
主要结局
the difference of eradication rates between 2 groups
时间窗: 5 months
次要结局
- the different rates of adverse events between 2 groups(5 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University
研究点 (1)
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