Prophylactic Efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients Continuously Treated With Low-dose Aspirin-Randomized, Multi-center, Single-blinded, Parallel-group, Comparative Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Endoscopic Recurrence of Gastric and/or Duodenal Ulcers
研究概览
简要总结
The aim of this study is to evaluate the efficacy of proton pump inhibitor (PPI), comparing to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular protection.
详细描述
The events of recurrence of gastric and/or duodenal ulcers will be evaluated due to a blinded manner by specialized endoscopists at pre- and post administration during 12 weeks administration of PPI (Rabeprazole sodium 10 mg or 20 mg tablet once a day) or the mucosal defensive drug (Gefarnate 50mg Capsule twice a day).
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
- Single (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
- •patients with ischemic heart failure or vascular disease of brain
- •patients taking low-dose aspirin to prevent relapse of vascular diseases
- •patients who experienced gastric and/or duodenal ulcers before the study by the endoscopy
- •patients without active gastric and duodenal ulcers
- •more than 20 years old
- •outpatients
- •patients written an informed consent
排除标准
- •patients with ischemic heart failure, which are acute phase, unstable condition or under 6 months after stent-instillation
- •patients with brain vascular disease , which are acute phase, unstable condition or under 3 months after the first attack
- •patients who are uncontrolled and complicated disease, for example thrombocytopenia, and unsuitable for this study as judged by investigator
- •patients who are treated with steroid hormones
- •patients who are women of, pregnant and lactating and childbearing
- •patients who are alcoholism
- •patients who show the hypersensitivity for test drugs
- •patients who are enrolled in another clinical study
- •patients who are judged as unsuitable by investigator
研究组 & 干预措施
Group I
Low-dose PPI (Rabeprazole sodium 10 mg)
干预措施: Low-dose PPI (Rabeprazole sodium) (Drug)
Group II
High-dose PPI (Rabeprazole sodium 20 mg)
干预措施: High-dose PPI (Rabeprazole sodium) (Drug)
Group III
Non-PPI (Gefarnate)
干预措施: Non-PPI (Gefarnate) (Drug)
结局指标
主要结局
Endoscopic Recurrence of Gastric and/or Duodenal Ulcers
时间窗: 12 weeks after giving medication
次要结局
- Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events(12 weeks after giving medication)