Comparison of the Eradication Rate Between 1- and 2-Week PPI Containing Therapies for Helicobacter Pylori Eradication
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 387
- 试验地点
- 1
- 主要终点
- the comparison with 7days and 14days eradication rate of PPI based therapy
研究概览
简要总结
It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP), 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7 or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended.
This study aims to investigate which duration would be better for eradication of HP. The study design is a randomized controlled trial. The patients were randomly assigned to 7 days or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in both groups.
详细描述
The recommended duration of triple therapy is typically 10 to 14 days in the United States and 7 days in Europe. In Korea, it is recommended as the first line treatment regimen, 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In case for treatment failure which is often related to Helicobacter pylori (HP) resistance to clarithromycin or metronidazole, bismuth-based quadruple therapy is commonly used as second-line therapy, however, the eradication rates was widely ranged according to the treatment duration.
The objective of the study is to investigate whether treatment duration would affect the eradication rate of HP as a PPI based triple therapy (1st line therapy) and a bismuth-based quadruple therapy (2nd line 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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peptic ulcer including ulcer scar
- •Early gastric cancer
- •Gastric mucosa-associated lymphoid tissue lymphoma
排除标准
- •operation history
- •liver cirrhosis
- •chronic kidney disease
- •pregnancy
结局指标
主要结局
the comparison with 7days and 14days eradication rate of PPI based therapy
时间窗: 12 months after randomization
次要结局
- the rate of side effects related to helicobacter eradication regimen(12 months after randomization)
研究者
JUNG HWAN OH
Associate Professor
St.Paul's Hospital, Korea