Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 1,045
- 试验地点
- 1
- 主要终点
- Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
研究概览
简要总结
The aim of the study was to evaluate the effect of pantoprazole on sleep disorders in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease). The prevalence and intensity of the sleep disorders were evaluated by a standardized questionnaire. The study was expected to provide further data on safety and tolerability of pantoprazole.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pantoprazole
All patients enrolled
干预措施: Pantoprazole (Drug)
结局指标
主要结局
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
时间窗: 7 days
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Physician's Assessment of Sleep Disturbances
时间窗: 7 days
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
时间窗: 7 days
Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts
次要结局
- Patient's Assessment of Nausea for the Last 24 Hours (Diaries)(7 days)
- Physician's Assessment of Heartburn(7 days)
- Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)(7 days)
- Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)(7 days)
- Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)(7 days)
- Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)(7 days)
- Physician's Assessment of Acid Eructation(7 days)
- Physician's Assessment of Painful Swallowing(7 days)
- Assessment of the Tolerability of Pantoprazole at Final Visit(7 days)
- Assessment of the Efficacy of Pantoprazole at Final Visit(7 days)