NCT00701259已完成3 期
A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of Fourteen Day Treatment With Lansoprazole 15 mg or 30 mg Once a Day in Frequent Nighttime Heartburn
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
- Novartis
- 入组人数
- 852
- 试验地点
- 1
- 主要终点
- Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.
研究概览
简要总结
Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime 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
- Triple (Participant, Care Provider, Investigator)
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 during the nighttime period 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/exclusion criteria may apply"
研究组 & 干预措施
2
Experimental
30 mg lansoprazole
干预措施: Lansoprazole (Drug)
1
Experimental
15 mg lansoprazole
干预措施: Lansoprazole (Drug)
3
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.
时间窗: 14 days
次要结局
- Proportion of 24 hour days with no heartburn during 14 days of treatment. Proportion of subjects with no heartburn during day 1 (the 24 hours following the first dose. The evaluation of lansoprazole safety.(14 days)
研究者
研究点 (1)
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