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临床试验/NCT00520949
NCT00520949已完成不适用

Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy

Aga Khan University1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2006年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
176
试验地点
1
主要终点
Eradication of H. pylori infection resistant to triple therapy.

研究概览

简要总结

Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an increasing evidence of H. pylori resistance to classical triple therapy. Another reason for this failure being low patient compliance with treatment. A regimen useful in one geographical area may not be effective or practical in another area. The aim of this study was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 14 days.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

入选标准

  • Informed consent given by the patient
  • Patients known to have H. pylori infection diagnosed by histopathology, rapid urease test and urea breath test
  • Failure to respond to classical triple regime of amoxicillin 1gram, clarithromycin 500mg and omeprazole 20mg twice a day for 10-14 days as documented by repeat urea breath test done one month after eradication therapy

排除标准

  • Evidence of any malignancy, gastric outlet syndrome, history of gastric surgery, chronic liver disease, severe chronic renal failure, or any major co-morbidity.
  • known or suspected hypersensitivity to the medication used in the study

研究组 & 干预措施

Quadruple Therapy

Experimental

干预措施: Augmentin (Amoxicillin-clavulanic) (Drug)

Quadruple Therapy

Experimental

干预措施: Furoxone (furazolidone) (Drug)

Quadruple Therapy

Experimental

干预措施: Cebes (colloidal bismuth subcitrate) (Drug)

Quadruple Therapy

Experimental

干预措施: Esso (esomeprazole) (Drug)

结局指标

主要结局

Eradication of H. pylori infection resistant to triple therapy.

时间窗: 6 weeks

次要结局

  • Safety of the quadruple therapy(6 weeks)

研究者

申办方类型
Other

研究点 (1)

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