NCT01397448已完成2 期
Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment. - A Multicenter, Randomized, Parallel-group, Double-blind Comparative Trial-
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 472
- 主要终点
- Cumulative Recurrent Rates of Gastric or Duodenal Ulcers
研究概览
简要总结
The primary objective of this study to evaluate the effect of preventing recurrence of gastric or duodenal ulcers by administering E3810 5 mg or 10 mg tablets once daily or Teprenone 150 mg/day (50 mg three times daily) as a control to patients receiving low-dose aspirin and thereby examine the superiority of E3810 over Teprenone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
E3810 5 mg
Experimental
干预措施: E3810 (Drug)
E3810 10 mg
Experimental
干预措施: E3810 (Drug)
Teprenone 150 mg
Active Comparator
干预措施: Teprenone (Drug)
结局指标
主要结局
Cumulative Recurrent Rates of Gastric or Duodenal Ulcers
时间窗: 24 weeks
Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.
次要结局
- Cumulative Incidence of Bleeding Ulcers(24 weeks)
研究者
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