A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With Tegoprazan, 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
- 284
- 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 tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in H. pylori positive patients.
详细描述
This is a randomized, double blind, active controlled, multicenter, Phase 3 study to demonstrate the non-inferiority of tegoprazan triple therapy (TAC) to lansoprazole triple therapy (LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan in H. pylori positive patients after oral administration of therapy for 7 days, twice daily. 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 based on the screening test
- •Peptic ulcer disease
排除标准
- •Prior treatment for H. pylori eradication
- •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
Tegoprazan/Amoxicillin/Clarithromycin
Tegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
干预措施: Tegoprazan/Amoxicillin/Clarithromycin (Drug)
Lansoprazole/Amoxicillin/Clarithromycin
Lansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
干预措施: Lansoprazole/Amoxicillin/Clarithromycin (Drug)
结局指标
主要结局
H. pylori eradication rate
时间窗: 6 weeks
Subjects will be considered to succeed in achieving H. pylori eradication if subjects's negative UBT test.
次要结局
未报告次要终点