NCT00633412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 in Subjects in the US Only
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
- The proportion of patients with no gastric ulcers after 8 weeks of treatment.
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 for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily for subjects in the US only.
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
- Double
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
- •A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.
- •A gastric ulcer >= 5mm in diameter, but no ulcer >25 mm at its greatest diameter, at the baseline endoscopy.
- •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.
- •Many 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
The proportion of patients with no gastric ulcers after 8 weeks of treatment.
时间窗: Esophagogastroduodenscopy (EGD) assessments at baseline, week 4, week 8, and efficacy evaluations at each visit including endoscopic evaluation for the presence of ulcers and erosions.
次要结局
- The patient and investigator symptoms, defined as control of NSAID-associated GI symptoms up to 8 weeks of treatment with esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily N(Assessments at Week 0, Week 4 and Week 8)
- To look at any side effects of esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily NSAID therapy.(Assessments at Week 0, Week 4 and Week 8)
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