Efficacy of Tegoprazan-containing Sequential Therapy Compared to Proton Pump Inhibitor-based Eradication in South Korea, a Region With High Antimicrobial Resistance: A Prospective Randomized Single Tertiary Center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Eradication rate
研究概览
简要总结
As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy
详细描述
Eradication treatment containing potassium-competitive acid blocker has shown acceptable eradication efficacy. In regions such as Korea, where the prevalence of antimicrobial resistance is high, alternative combinations of antibiotics such as sequential or concomitant therapy are needed. This study compared the outcome of sequential therapy containing tegoprazan, a new potassium-competitive acid blocker, with the conventional esomeprazole-containing sequential therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who had H. pylori infection proved by positive test result of urea breath test (UBT), rapid urase test or pathologic examination (warthin-giemsa staining)
排除标准
- •congestive heart failure, NYHA III or IV
- •end-stage renal disease
- •alcoholics
- •drug abusers
- •pregnant or nursing women
研究组 & 干预措施
Esomeprazole-containing sequential H. pylori eradication therapy (conventional method)
esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days.
干预措施: Esomeprazole-containing sequential H. pylori eradication therapy (Drug)
Tegoprazan-containing sequential H. pylori eradication therapy (experimental method)
tegoprazan (50 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days.
干预措施: Tegoprazan-containing sequential H. pylori eradication therapy (Drug)
结局指标
主要结局
Eradication rate
时间窗: 2 or 3 month
Efficacy of H. pylori eradication therapy. confirmed by negative UBT test
次要结局
- Adverse events(up to 6 month)
研究者
Nayoung Kim
Professor
Seoul National University Bundang Hospital