Rabeprazole Based Sequential-Concommitant Hybrid Therapies for H. Pylori Infections
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Eradication rate
研究概览
简要总结
This prospective controlled randomized open-label clinical trial is designed to determine the optimal eradication rate of rabeprazole based sequential-concommitant hybrid therapies for adults infected with Helicobacter pylori in Eastern Taiwan. Enrolled patients will receive 3, 5 or 7 days of pre-concommitant (sequential part) treatment with rabeprazole + amoxicillin, then 7 days of concommitant treatment with rabeprazole + amoxicillin + clarithromycin + metronidazole.
详细描述
Background: Antimicrobial resistance has decreased the worldwide eradication rates of common used triple therapy for Helicobacter pylori infection (less than 80%).
Objective: To determine the optimal pre-concommitant treatment length for rabeprazole based sequential-concomitant hybrid therapies for adults infected with Helicobacter pylori in Eastern Taiwan.
Design: Randomized, open-label, prospective controlled trial.
Patients: 231 patients with dyspepsia or peptic ulcers and infected by Helicobacter pylori.
Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient proved with infection of H. pylori in gastric mucosa (at least two of four tests positive)
排除标准
- •woman in breast feeding or pregnancy.
- •allergy to drugs used in study.
- •previously treated for H. pylori.
- •intolerance to fructose, lactose.
- •patients with hematologic, brain or spinal disorders
- •patients under 20 years old
- •patients under aspirin or clopidogrel
- •patients with history of gastric cancer or gastric resection operation.
研究组 & 干预措施
Hybrid-10
RA3-RACM7: rabeprazole + amoxicillin x 3 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days.
干预措施: RA3-RACM7 (Drug)
Hybrid-12
RA5-RACM7: rabeprazole + amoxicillin x 5 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days
干预措施: RA5-RACM7 (Drug)
Hybrid-14
RA7-RACM7: rabeprazole + amoxicillin x 7 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days
干预措施: RA7-RACM7 (Drug)
结局指标
主要结局
Eradication rate
时间窗: 4 weeks after complete use of drug for treatment
A negative post-treatment 13C-urea breath test result at more than 4 weeks after complete use of drug for treatment.
次要结局
未报告次要终点
研究者
Ming-Cheh Chen
Principal Investigator
Buddhist Tzu Chi General Hospital