NCT00206024已完成4 期
A 4-week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 330
- 试验地点
- 27
- 主要终点
- Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of "None".
研究概览
简要总结
This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-lactating females, aged 18 to 75 years, inclusive, with the ability to understand English and provide written informed consent
- •A history of heartburn for at least 6 months
- •A history of prior positive relief of heartburn symptoms from antacids or acid suppressive therapy
- •A positive esophageal acid perfusion test
- •At least 3 days of 'moderate' severity heartburn over the previous 7 days
- •No use of any acid suppression therapy (PPI, H2RA, etc.) within 14 days of randomization
排除标准
- •A history of gastric or esophageal surgery
- •H. pylori positive
- •A history of endoscopy -verified erosive esophagitis within the 16 weeks prior to randomization
- •Currently taking higher than the standard approved proton pump inhibitor doses
- •Historical evidence of a number of other GI, cardiovascular, pulmonary, liver, kidney, pancreatic, cerebral vascular diseases, organ transplant, or a condition requiring surgery.
结局指标
主要结局
Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of "None".
次要结局
- Relief of heartburn during the 4th week of treatment
- Cumulative daily sustained resolution rate through 4 weeks of treatment
- Time to first day of the first 7-day period of sustained resolution of heartburn
- Time to the first day of the first 7-day period of relief of heartburn
- Percentage of subject-reported heartburn-free days through 4 weeks of treatment
- Percentage of subject-reported heartburn-free nights through the 4 weeks of treatment
- Safety and tolerability: adverse events, clinical laboratory tests, vital signs, physical examination.
研究者
研究点 (27)
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