NCT00562094已完成不适用
Pantoprazole for the Treatment of GERD Associated Symptoms Focusing on Sleep Disorders.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 8,616
- 试验地点
- 1
- 主要终点
- Assessment of the Severity of Sleep Disturbances
研究概览
简要总结
The aim of the study was to evaluate the effect of Pantoprazole 20 mg/40 mg for 14 days on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) with special focus on the reduction of symptomatic sleep disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
干预措施: Pantoprazole (Drug)
结局指标
主要结局
Assessment of the Severity of Sleep Disturbances
时间窗: first and last visit (after a median of 18 days)
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Assessment of Change of Quality of Sleep During Therapy With Pantoprazole
时间窗: last visit (after a median of 18 days)
Physician's assessment on a scale with * considerably improved * improved * unchanged
次要结局
- Assessment of the Severity of Heartburn(first and last visit (after a median of 18 days))
- Assessment of the Severity of Eructation/Acid Eructation(first and last visit (after a median of 18 days))
- Assessment of the Severity of Epigastric Complaints/Epigastric Pain(first and last visit (after a median of 18 days))
- Assessment of the Severity of Sensation of Fullness/Abdominal Distension(first and last visit (after a median of 18 days))
- Assessment of the Efficacy of Pantoprazole at Final Visit(last visit (after a median of 18 days))
- Assessment of the Tolerability of Pantoprazole at Final Visit(last visit (after a median of 18 days))
研究者
研究点 (1)
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