Pantoprazole 20 mg/40 mg for the Treatment of Gastroesophageal Reflux Disease (GERD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 1,995
- 试验地点
- 1
- 主要终点
- Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)
研究概览
简要总结
The aim of the study was to evaluate the effect of 7 days treatment with Pantoprazole 40 mg and 20 mg on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) in clinical practice. During the study, the patients had to complete a short version of a patient-orientated, self-assessed reflux questionnaire (ReQuest™ in Practice).
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 General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)
时间窗: 7 days
Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad
Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
时间窗: 7 days
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
时间窗: 7 days
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
时间窗: 7 days
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)
时间窗: 7 days
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)
时间窗: 7 days
Assessment on a scale: Severity from 0=None to 10=Extremely strong
次要结局
- Physician's Assessment of Heartburn(7 days)
- Physician's Assessment of Acid Eructation(7 days)
- Physician's Assessment of Painful Swallowing(7 days)
- Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit(7 days)
- Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit(7 days)