NCT00633672已完成3 期
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued
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
- 400
- 主要终点
- To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.
研究概览
简要总结
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
- •Other key inclusion criteria, as specified in the protocol.
排除标准
- •History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
- •History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- •Other conditions and criteria, as specified in the protocol.
研究组 & 干预措施
1
Experimental
20mg Oral tablet daily
干预措施: Esomeprazole (Drug)
2
Experimental
40mg oral tablet daily
干预措施: Esomeprazole (Drug)
3
Active Comparator
150mg oral twice daily
干预措施: Ranitidine (Drug)
结局指标
主要结局
To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers.
次要结局
- Patient and investigator assessed GI symptoms for up to 8 weeks of treatment.(Assessments at week 0, week 4 and week 8)
- Safety and tolerability of the treatments for 8 weeks of treatment.(Assessments at week 0, week 4 and week 8)
研究者
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