NCT03315676招募中2 期
RCT Using Bonopurazan or Esomeprazole in Patients With NSAIDs-induced Erosions and/or Ulcers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Number of participants with healing of gastrointestinal erosions and/or ulcers using major forceps
研究概览
简要总结
The aim of this study is to collect the data of clinical efficacy and safety after the usage of bonoprazon and esomeprazole when the patients take NSAIDs more than 2 weeks and have gastrointestinal symptoms who have had gastrointestinal erosions and/or ulcers in the past.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of NSAIDs-induced gastrointestinal Erosions and/or Ulcers who want to take Bonoprazan or Esomeprazole
排除标准
- •Patients allergic to Bonoprazan or Esomeprazole
研究组 & 干预措施
Oral Bonoprazan
Active Comparator
Daily intake of Bonoprazan
干预措施: Oral Bonoprazan (Drug)
Oral Esomeprazol
Active Comparator
Daily intake of Esomeprazol
干预措施: Oral Esomeprazol (Drug)
结局指标
主要结局
Number of participants with healing of gastrointestinal erosions and/or ulcers using major forceps
时间窗: Change from Baseline Gastrointestinal erosions and/or ulcers at 2 weeks
次要结局
未报告次要终点
研究者
Yukio Nakamura
Lecturer at Shinshu University School of Medicine
Shinshu University
研究点 (1)
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