A Cross-Sectional, Canadian, Multi-Centre Study of Symptom Burden and Clinical Management in Subjects With Gastroesophageal Reflux Disease (GERD) RANGE: Retrospective ANalysis of GErd
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To describe the impact of reflux symptoms on subjects' daily life
研究概览
简要总结
This is a cross-sectional study of symptom burden and clinical management. A subset of patients who have attended the Primary Care (PC) office with reflux symptoms during a retrospective period of 4 months (Index Visit) are invited to complete health survey questionnaires and partake in a subject-physician/study nurse interview (Visit 1), in order to assess the type, intensity and frequency of GERD symptoms at both visits and describe the treatment provided. Additionally, the impact of GERD on subjects' life, productivity and willingness to pay for GERD symptom relief will be explored. This design will give a "real-life" clinical practice picture in a representative population of PC doctors and subjects.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
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
- •Provision of informed consent
- •Ability to complete PRO instruments (non-applicable to "non-attendees")
- •Subject with GERD symptom(s). At least presence of troublesome heartburn and/or regurgitation even if not specifically recorded at the Index Visit.
- •At least one visit during the Retrospective Visit Period (-6 to -2 months prior to study start).
- •In the reasons for the Index Visit section of the medical record mention of acid regurgitation and/or heartburn symptom(s) or GERD diagnosis or GERD complications has to be explicit or a treatment decision (prescription) in a previously diagnosed subject although no mention of symptoms is made.
排除标准
- •Prophylactic PPI use to reduce the risk of ulcers in subjects being treated with NSAIDs
- •PPI treatment to heal an ulcer induced by NSAID treatment
- •PPI treatment for H-pylori eradication
- •Participation in any other clinical study in the time window between the Index Visit and Visit 1
结局指标
主要结局
To describe the impact of reflux symptoms on subjects' daily life
时间窗: Assessed by means of the patient reported outcomes (PROs)
次要结局
- To describe the impact of reflux symptoms on work productivity(Assessed by means of the patient reported outcomes (PROs))