NCT00343161已完成4 期
A Randomized, Open, Parallel-group, Multi-national, Multi-centre, Phase IV Study to Evaluate the Efficacy of Three Different Patient Management Strategies With and Without Esomeprazole 20 mg During a 3 Months Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related
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
- 441
- 试验地点
- 96
- 主要终点
- To compare the efficacy of three different long-term treatment strategies in primary care setting
研究概览
简要总结
The purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Patients who seek medical advice in primary care for symptoms thought to be GERD-related
排除标准
- •Clinical GERD diagnosis/treatment within last 3 month
- •History of severe esophagitis (i.e. LA grade C or D)
- •Previous anti-reflux surgery
- •History of drug abuse
- •Female patients who are pregnant or lactating or at risk of pregnancy
结局指标
主要结局
To compare the efficacy of three different long-term treatment strategies in primary care setting
To compare treatments separately within different levels of symptom load according to clinical judgement at baseline
Number of 'treatment failures' used as primary outcome variable.
次要结局
- To evaluate whether the Reflux Disease Questionnaire (RDQ)used in primary care setting adds value to clinical judgement in assessing baseline symptom load
- Evaluate whether the RDQ facilitates the decision on appropriate acute and maintenance treatment strategy
- To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy
- To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale
研究者
研究点 (96)
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