A Randomized, Double-Blind, Active-controlled, Multi-center, Therapeutic Exploratory Study to Evaluate the Safety and Efficacy of a Standard Triple Therapy With Tegoprazan (by Dose) in H. Pylori Positive Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 381
- 试验地点
- 1
- 主要终点
- H. pylori eradication rate
研究概览
简要总结
This exploratory study is designed to compare safety and efficacy between a Tegoprazan dose-specific standard triple therapy and Lansoprazole standard triple therapy in H. pylori positive patients.
详细描述
A Randomized, Double-Blind, Active-controlled, Multicenter, Therapeutic Exploratory Study to to Evaluate the Safety and Efficacy of a Standard Triple Therapy with Tegoprazan and Lansoprazole standard triple therapy in H. pylori Positive Patients, twice a day for 14 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •H. pylori positive at screening
- •Subjects who have upper gastrointestinal disease
排除标准
- •Having received prior therapy for eradication of H. pylori
- •Prior use of P-CAB, proton pump inhibitors (PPIs), H2 receptor blockers within 14 days
- •Prior use of H. pylori eradication effective antibiotics, bismuth within 28 days
研究组 & 干预措施
Tegoprazan 50 mg
Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
干预措施: Tegoprazan 50 mg Triple Therapy (Drug)
Tegoprazan 100 mg
Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
干预措施: Tegoprazan 100 mg Triple Therapy (Drug)
Lansoprazole
Lansoprazolee/Clarithromycin/ Amoxicillin BID peroral, 14 days
干预措施: Lansoprazole Triple Therapy (Drug)
结局指标
主要结局
H. pylori eradication rate
时间窗: 42 days
Assess H. pylori eradication rate by UBT
次要结局
未报告次要终点