Additive Effect of Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications; an Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Overall compliance of eradication medication
研究概览
简要总结
Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment. The aim of this study was to evaluate the additive effect of trimebutine for the development of adverse events related to the H. pylori eradication regimen.
详细描述
Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment. The common adverse events related to the eradication medications area as follows; Abdomen discomfort, pain, nausea, vomiting, diarrhea, bloating, urticaria, dizziness, headache, etc,. Various methods have been tried to reduce or prevent the adverse events related to the eradication medications. However, there is no established methods to reduce or prevent these events.
The aim of this study was to evaluate the additive effect of trimebutine for the development of adverse events related to the H. pylori eradication regimen.
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
- •Subjects who underwent upper gastrointestinal endoscopy and were proven to have H. pylori infection either by using the rapid urease test, the 13 C-urea breath test (UBT), or histological examination.
排除标准
- •Subjects who took medications as Proton pump inhibitor, Histamin-2 receptor antagonist and antibiotics,
- •Subjects who underwent stomach resection
- •Subjects less than 18 years of age
研究组 & 干预措施
Trimebutine add group
Addition of Trimebutine on the Bismuth-containing quadruple regimen
干预措施: Trimebutine 100 MG (Drug)
结局指标
主要结局
Overall compliance of eradication medication
时间窗: 2 weeks after prescription of eradication medication
How much the enrolled subjects took prescribed eradication medication
次要结局
- Adverse events related to eradication medication(2 weeks and 6 weeks after prescription of eradication medication)
研究者
Chang Seok Bang
Associate professor
Chuncheon Sacred Heart Hospital