KCT0001176招募中未知
A prospective, multi-center, randomized, open-label, parallel design clinical trial to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy for the eradication of Helicobacter pylori in Korea.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 390
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Male and female Korean Adult (Aged = 18 years)
- •2) Patients who diagnosis of H. pylori infection by any of following three methods
- •? positive rapid urease test (CLOtest)
- •? histologic evidence of H. pylori by modified Giemsa staining
- •? positive 13C-urea breath test
- •3) Subjects who want to participate this clinical trial and have signed the
- •informed consent document
- •4) Subject who understand and complete all the questions on the questionnaires
排除标准
- •1) Age under 18 years
- •2) Previous eradication treatment for H. pylori
- •3) Patients who took any drug which could influence the study results such as
- •proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
- •4) History of gastrectomy
- •5) Advanced gastric cancer or other malignancy
- •6) Abnormal liver function or liver cirrhosis
- •7) Abnormal renal function or chronic kidney disease
- •8) Other severe concurrent diseases
- •9) Previous contraindication or allergic reactions to the study drugs
- •10)Patients with genetic disorder - galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •11)Patients with mental disorder, alcohol or drug addiction
- •12)Pregnant or lactating women or women who disagree to use an appropriate method of contraception through the course of this study
- •13)Patients who has some conditions to affect the evaluation of the clinical results by the judgement of the principal investigator or sub-investigator
- •14)Specific contraindication to the study drugs
研究者
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