NCT00389948已完成3 期
A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 576
- 试验地点
- 50
- 主要终点
- To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo.
研究概览
简要总结
Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.
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
- •Experiencing heartburn at least 2 days per week over the past month.
- •Having heartburn that responds to heartburn medication.
- •Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.
排除标准
- •Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).
- •Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.
- •Other protocol-defined inclusion or exclusion criteria may apply
结局指标
主要结局
To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo.
次要结局
- To determine the proportion of nighttimes with no heartburn during 14 days of treatment in subjects receiving lansoprazole versus placebo
- To determine the proportion of subjects with no heartburn during day 1 in those receiving lansoprazole versus placebo
- Evaluation of lansoprazole safety.
研究者
研究点 (50)
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