NCT01130935已完成不适用
A National, Multicentre, Open-label, Non-comparative, Non-interventional Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 491
- 试验地点
- 1
- 主要终点
- Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.
研究概览
简要总结
This study will assess the effectiveness of Nexium at alleviating upper GI symptoms in subjects and evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have had upper GI symptoms requiring acid suppression treatment
- •Treatment with Nexium is in accordance with indications and dosing approved in Albania.
- •Start of treatment at least 2 weeks prior to enrollment to this study
- •Written informed consent is signed.
排除标准
- •Known hypersensitivity to Nexium or any other constituents of the formulation
- •Concomitant administration of atazanavir and nelfinavir.
- •Alarming upper GI symptoms (i.e. significant unintended weight loss, vomiting, dysphasia, hematemesis, melena, fever, jaundice or any other sign indicating serious or malignant disease
结局指标
主要结局
Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.
时间窗: Weeks 8-12
次要结局
- To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.(Weeks 8-12)
- Evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.(Once: Day 0)
- Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.(Weeks 8-12)
研究者
研究点 (1)
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