NCT00687336Unknown4 期
Phase IV Study Comparing Helicobacter Pylori Empiric Eradication With Test-Guided Treatment in Patients With Peptic Ulcer Bleeding
Hospital de Sabadell2 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2008年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
The goal of the study is to compare the effectiveness of empirical Helicobacter pylori treatment compared with treatment depending on diagnostic tests for Helicobacter pylori in patients with Upper gastrointestinal bleeding due to peptic ulcer. Main hypothesis is that empirical treatment will reduce the number of patients lost to follow-up thus improving the cure rates of Hp infection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than
- •Informed Consent signed.
- •Diagnosis of no variceal upper gastrointestinal bleeding secondary to a duodenal ulcer, erosive duodenitis or gastric ulcer.
- •Life expectancy longer than 6 months.
- •Able to attend further clinical controls.
- •Absence of the following
排除标准
- •Exclusion Criteria:
- •Previous eradication treatment.
- •Use of antibiotics 2 weeks prior to inclusion.
- •Need for Antisecretor treatment that cannot be stopped to perform the breath test.
- •Pregnancy or breastfeeding.
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: two years
次要结局
- Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment.(two years)
研究者
研究点 (2)
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