Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 29,586
- 主要终点
- efficacy and tolerability of esomeprazole in patients who are treated by general practitioners and internists
研究概览
简要总结
Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. general practitioners and internists) are asked to document relevant data related to esomeprazole therapy in patients with gastrointestinal disorders. Patients with acid associated gastrointestinal symptoms can be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.
排除标准
- •limitiations; possible risks; warnings; contraindications mentioned in the SPC.
结局指标
主要结局
efficacy and tolerability of esomeprazole in patients who are treated by general practitioners and internists
时间窗: proportion of treated subjects without any specific acid associated symptoms at the end of the study; change in intensity of specific acid associated symptoms; incidence of the occurrence of unknown, unexpected and/or rarely occurring adverse events AE.
次要结局
- evaluation of a diagnosis tool(evaluation of the predictive value of a two items questionnaire on acid associated symptoms)