Evaluation of the Efficacy of Concomitant Therapy for Eradication of Helicobacter Pylori
试验速览
- 阶段
- 4 期
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori
研究概览
简要总结
If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin, rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days(sequential), amoxicillin, clarithromycin, metronidazole, rabeprazole(concomitant), then the eradication rate of concomitant group will be the highest.
详细描述
- Subject: The patient of gastritis, gastric ulcer, and duodenal ulcer infected with Helicobacter pylori
- 170 subjects per group
- Eradication regimens are as follows: AOC group, treated with amoxicillin, rabeprazole, clarithromycin for 7 days; AOM group, treated with amoxicillin, rabeprazole, metronidazole for 7 days; sequential group, treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days; concomitant group, treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients infected with Helicobacter pylori
排除标准
- •pregnancy
- •formerly treated with eradication
研究组 & 干预措施
AOC group
AOC group: treated with amoxicillin, rabeprazole, clarithromycin for 7 days
干预措施: amoxicillin, clarithromycin, metronidazole, rabeprazole (Drug)
AOM group
AOM group: treated with amoxicillin, rabeprazole, metronidazole for 7 days
干预措施: amoxicillin, clarithromycin, metronidazole, rabeprazole (Drug)
Sequential group
Sequential group: treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days
干预措施: amoxicillin, clarithromycin, metronidazole, rabeprazole (Drug)
concomitant group
concomitant group: treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days
干预措施: amoxicillin, clarithromycin, metronidazole, rabeprazole (Drug)
结局指标
主要结局
Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori
时间窗: 6 months (Feb 2014)
measure eradication rate of H.pylori with urea breath test(UBT) after 6 to 8 weeks of treatment
次要结局
未报告次要终点
研究者
Jin Il Kim
MD, PhD
The Catholic University of Korea