NCT00595517已完成3 期
A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period
研究概览
简要总结
The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Medical history of gastric and/or duodenal ulcer
- •A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age
排除标准
- •Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
- •History of esophageal, gastric or duodenal surgery
- •Having severe liver disease or chronic renal disease
研究组 & 干预措施
Esomeprazole 20 mg
Experimental
Esomeprazole 20 mg once daily
干预措施: Esomeprazole 20 mg (Drug)
结局指标
主要结局
Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period
时间窗: up to 52 weeks
次要结局
- Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment(up to 12 weeks after treatment)
- Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment(up to 24 weeks after treatment)
- Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment(up to 4 weeks after treatment)
研究者
研究点 (1)
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