NCT01199536已完成不适用
Observational Study to Evaluate Helicobacter Pylori Eradication at the End of Routine Triple Eradication Therapy With Duodenal Ulcer Relapses Control.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Eradication rate of H. pylori at the end routine triple eradication therapy
研究概览
简要总结
The Study purpose is to evaluate Helicobacter pylori susceptibility to Clarithromycin and to estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the end of treatment and 52 weeks from the therapy start
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Active duodenal ulcer with duodenal ulcer exacerbation confirmed by endoscopic signs of duodenal ulcer disease (acute ulcer or scar deformity of the duodenal bulb) and anamnesis data.
- •Helicobacter pylori positive diagnosis at entry by 13C-Urea Breath Test (UBT)
- •Prescription of the standard 7-day eradication therapy including esomeprazole 20 mg bd, amoxicillin 1000 mg bd, clarithromycin 500 mg bd
- •Written informed consent provided prior the start of participation in the study.
排除标准
- •Subjects who are unwilling or unable to provide informed consent
- •Current complication of duodenal ulcer disease, e.g. perforation, bleeding or pyloric stenosis
- •History of esophageal/gastric/duodenal surgery except of the patients underwent perforated ulcer closure or endoscopic hemostasis more than 6 months ago
- •Contraindications to Esomeprazole, Amoxicillin or Clarythromycin including known or suspected hypersensitivity or allergy
- •Treatment with Amoxicillin, Clarythromycin or Bismuth containing drugs one month prior to inclusion
- •Two or more previous attempts to eradicate H. Pylori
结局指标
主要结局
Eradication rate of H. pylori at the end routine triple eradication therapy
时间窗: 1 year
次要结局
- Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage)(2 years)
- Frequency of duodenal ulcer relapses(2 years)
研究者
研究点 (1)
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