NCT00251901已完成3 期
A Randomized Double-Blind Placebo-Controlled Multi-Centre Pilot Study to Assess Symptom Response in Subjects With Pain or Discomfort in the Chest Receiving Oral Treatment With Esomeprazole 40 mg Bid for 4 Weeks.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 600
- 试验地点
- 76
- 主要终点
- Relief of pain or discomfort in the chest during the last week of the 4-week treatment course.
研究概览
简要总结
The purpose of this study is to compare the efficacy of Nexium® with placebo in relief of acid related pain or discomfort in the chest.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain or discomfort in the chest without any identifiable cause and severe enough for the patient to seek primary medical or similar care.
- •History of pain or discomfort in the chest for at least the last two weeks prior to enrollment.
排除标准
- •Signs, symptoms or relevant investigations suggestion present symptomatic coronary heart disease.
- •Patients whose pain or discomfort in the chest warrants urgent cardiac investigation.
结局指标
主要结局
Relief of pain or discomfort in the chest during the last week of the 4-week treatment course.
Relief of pain or discomfort in the chest is defined as no more than one day with minimal symptoms according to the patients assessment
次要结局
- Symptom response during the first week is based on diary cards, days 3-7.
- The investigator's overall assessment of pain or discomfort in the chest during the first and fourth week.
- Scores from the PRO instruments measuring pain, HRQL, anxiety and depression, health status, reflux related symptoms and overall treatment evaluation.
- Adverse events, clinical laboratory variables and vital signs.
研究者
研究点 (76)
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