NCT00272701已完成4 期
A Randomised, Open, Phase IV, Parallel Group Multicentre Study to Evaluate a Change of Management in Gastroesophageal Reflux Disease (GERD) Patients by Treatment With Esomeprazole 40 mg or Any Other Proton Pump Inhibitor (PPI), After Initial Treatment Failure, in Ordinary Clinical Practice During 4 Weeks.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 450
- 试验地点
- 44
- 主要终点
- The proportion of patients free from heartburn
研究概览
简要总结
The purpose of this study is to assess how PPI treated GERD patients with insufficient symptom control will benefit from a change in management by providing a more efficient acid secretion inhibition during 4 weeks, by evaluation of esomeprazole 40 mg compared to pre-study PPI treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Male or female, aged 18-65 years
- •History of GERD symptoms during, at least, six months prior to enrolment
- •PPI as maintenance treatment during the last 30 days prior to enrolment
- •Heartburn as predominant GERD symptom, as judged by the investigator
- •Persisting GERD symptoms during the past 7 days prior to visit 1, judged by the patient as either: 4 days with mild symptoms (i.e. awareness of sign or symptom, but easily tolerated)or 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities)
排除标准
- •Any treatment with esomeprazole during 30 days prior to enrolment History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer
- •Current or historical evidence of the following diseases/conditions, as judged by the investigator:Zollinger-Ellison syndrome,Primary esophageal motility disorder, i.e. achalasia, scleroderma, primary esophageal spasm,
- •Gastric or duodenal ulcers within the last three months, Malabsorbtion
- •Malignancy or other concomitant disease with poor prognosis or which may interfere with the assessments in the study
- •Unstable diabetes mellitus. Stable diabetes controlled by diet, oral agents or insulin is acceptable
- •Patients with severe diseases or disorders which may interfere with the conduct of the study
结局指标
主要结局
The proportion of patients free from heartburn
次要结局
- Work Productivity and Activity Impairment Questionnaire: Gastro-Esophageal Reflux Disease questionnaire.
- EuroQol 5D questionnaire.
- Quality Assurance of GERD Treatment Questionnaire
- Willingness to pay
- Serious Adverse Events and Discontinuations due to Adverse Events
研究者
研究点 (44)
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