NCT00542789已完成3 期
A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo 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
- 343
- 试验地点
- 1
- 主要终点
- Absence of 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 efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers
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
- •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
1
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
2
Experimental
Esomeprazole 20 mg
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
时间窗: each visit up to 24 weeks
The absence of gastric and/or duodenal ulcer throughout the treatment period
次要结局
- Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment(up to 4 weeks)
- Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment(up to 12 weeks)
研究者
研究点 (1)
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