NCT04674774Unknown不适用
Efficacy of Tegoprazan Based Bismuth Quadruple Therapy Compared With Bismuth Quadruple Therapy for Helicobacter Pylori Infection: Randomized, Double-blind, Active-Controlled Study
Incheon St.Mary's Hospital1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2021年3月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- H. pylori eradication rate of each group
研究概览
简要总结
This study aims to investigate eradication rate, drug compliance, and adverse events in patients with confirmed Helicobacter pylori infection between tegoprazan, bismuth, metronidazole, and tetracycline for 14 days (TBMT) and PPI, bismuth, metronidazole, and tetracycline for 14 days (LBMT)
详细描述
This is a multi-center, double-blind, randomized, active-controlled study.
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
- Double (Participant, Investigator)
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
- •patients who male or female aged 19 to 75 years old and fall under the following conditions with confirmed helicobacter pylori infection
排除标准
- •patients who have H.pylori eradication history
- •patients with history of gastric cancer surgery
- •patients who have taken antibiotics within 4 weeks prior to trial
- •a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine
- •pregnant or breastfeeding women
研究组 & 干预措施
tegoprazan based bismuth quadruple therapy group
Experimental
tegoprazan based bismuth quadruple therapy group
干预措施: Tegoprazan (Drug)
PPI based bismuth quadruple therapy group
Active Comparator
PPI based bismuth quadruple therapy group
干预措施: Lansoprazole (Drug)
结局指标
主要结局
H. pylori eradication rate of each group
时间窗: UBT test 4 weeks after completion of eradication treatment
H. pylori eradication rate of each group
次要结局
未报告次要终点
研究者
Joon Sung Kim
Assistant Professor
Incheon St.Mary's Hospital
研究点 (1)
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