A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With CJ-12420, Amoxicillin and Clarithromycin in H. Pylori Positive Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- H. pylori eradication rate
研究概览
简要总结
The current study is designed to demonstrate the non-inferiority of CJ-12420-based triple therapy (CJ-12420, amoxicillin and clarithromycin) versus lansoprazole-based triple therapy (lansoprazole, amoxicillin and clarithromycin) in H. pylori eradication rate and to evaluate the safety of CJ-12420 following oral administration of either triple therapy twice daily for 7 days in H. pylori positive patients.
详细描述
This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (CJ-12420 50mg, lansoprazole 30mg). All subjects will be asked to take 5 tablets include clarithromycin, amoxicillin twice a day for 7 days.
After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •H. pylori-positive at screening
- •Complain of gastric discomfort symptom
排除标准
- •Having received prior therapy for eradication of H. pylori
- •Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days
- •Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days
研究组 & 干预措施
CJ-12420/Clarithromycin/Amoxicillin
CJ-12420 50mg /Clarithromycin 500mg /Amoxicillin 1g
干预措施: CJ-12420/Clarithromycin/Amoxicillin (Drug)
Lansoprazole/Clarithromycin/Amoxicillin
Lansoprazole 30mg /Clarithromycin 500mg /Amoxicillin 1g
干预措施: CJ-12420/Clarithromycin/Amoxicillin (Drug)
结局指标
主要结局
H. pylori eradication rate
时间窗: twice a day
Subjects will be considered to succeed in achieving H. pylori eradication if subject's UBT test (Eradication Assessment)
次要结局
未报告次要终点