Once Daily Dose Dexlansoprazole Levofloxacin Based Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Eradication rate (percentage)
研究概览
简要总结
New drug regimen for Helicobacter pylori eradication, the investigators compare once daily dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.
详细描述
Once daily dose dexlansoprazole should be non inferior to twice daily dose in the eradication of Helicobacter pylori infection.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 year-patient
- •Diagnosed as positive Helicobacter Pylori testing by any of the following methods:
- •Rapid urease test or Histology
- •Inform consent
排除标准
- •Previous history of Helicobacter pylori eradication
- •Contraindications or allergic reactions to the study drugs
- •Previous gastric surgery or advanced gastric cancer or other malignancy or other severe concurrent diseases
- •Decompensated Liver cirrhosis or chronic kidney disease (GFR< 30)
- •Mental disorders or alcohol or drug addiction
- •Pregnancy or lactation
研究组 & 干预措施
Once daily dose dexlansoprazole
Group 1 Dexlansoprazole 60 mg by oral once daily for 14 days (Levofloxacin 500 mg by oral once daily for 14 days Amoxicillin 1000 mg by oral bid for 14 days Bismuth 1048 mg by oral bid for 14 days)
干预措施: Dexlansoprazole 60 mg once daily (Drug)
Twice daily dose dexlansoprazole
Group 2 Dexlansoprazole 60 mg oral bid 14 Days (Levofloxacin 500 mg od oral 14 Days Amoxicillin 1000 mg bid oral 14 Days Bismuth 1048 mg bid oral 14 Days)
干预措施: Dexlansoprazole 60 mg once daily (Drug)
结局指标
主要结局
Eradication rate (percentage)
时间窗: Jan17-Nov17, Total 11 months
Compare eradication rate of helicobacter pylori between 2 groups
次要结局
- To compare drug compliance(jan17-Nov17, Total 11 months)
- To compare drug adverse event(jan17-Nov17, Total 11 months)
研究者
Parin siriwat
Fellowship of Gastroenterology Unit, Ramathibodi Hospital
Ramathibodi Hospital