NCT00629928已完成3 期
A Comparative Efficacy and Safety of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric and Duodenal Ulcers Associated With Daily NSAID Use in Patients at Risk
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
- 800
- 主要终点
- To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of treatment for the prevention of gastric (and duodenal) ulcers in patients receiving daily NSAID therapy.
研究概览
简要总结
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No active/current gastric or duodenal ulcer on baseline endoscopy.
- •A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
- •Other inclusion criteria, as defined in the protocol.
排除标准
- •History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.
- •History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- •Other criteria, as defined in the protocol.
研究组 & 干预措施
1
Experimental
20mg capsule once daily
干预措施: Esomeprazole (Drug)
2
Experimental
40mg capsule daily
干预措施: Esomeprazole (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of treatment for the prevention of gastric (and duodenal) ulcers in patients receiving daily NSAID therapy.
时间窗: Assessments at Week 0, Week 4, Week 12, Week 26
次要结局
- Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo when administered for up to 6 months to patients receiving daily NSAID therapy.(Assessments at Week 0, Week 4, Week 12, Week 26)
- Investigator assessed symptoms, defined as control of NSAID-associated GI symptoms for up to 6 months of treatment with esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo in patients receiving daily NSAID therapy.(Assessments at Week 0, Week 4, Week 12, Week 26)
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