A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Number of Participants in Whom Peptic Ulcer Was Healed
研究概览
简要总结
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.
详细描述
The aims of this study are to compare esomeprazole plus aspirin with esomeprazole alone in the treatment of aspirin-related ulcers.
Patients with aspirin-related peptic ulcers are randomized to receive esomeprazole (40 mg/day) plus aspirin (100 mg/day) or esomeprazole (40 mg/day) alone for 8 weeks. Follow-up endoscopy was carried out at the end of the eighth week. The primary end point was the healing of peptic ulcers.
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
- 否
入选标准
- •aspirin users who have a peptic ulcer confirmed by endoscopy
排除标准
- •serious medical illness (including cardiovascular events within 6 months before endoscopy)
- •acute gastrointestinal bleeding
- •a history of gastric or duodenal surgery
- •allergic to the study drugs
- •require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents
- •pregnancy
研究组 & 干预措施
esomeprazole plus aspirin
esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
干预措施: aspirin (Drug)
结局指标
主要结局
Number of Participants in Whom Peptic Ulcer Was Healed
时间窗: 8 weeks
Number of participants in whom peptic ulcer was healed at week 8
次要结局
- Number of Participants Deveoping Peptic Ulcer Bleeding(8 weeks)
研究者
Ping-I (William) Hsu, M.D.
Professor
Kaohsiung Veterans General Hospital.