NCT01753128已完成3 期
Efficacy of Imipramine for Treatment of Patients With Esophageal
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- improvement of GERD score
研究概览
简要总结
Esophageal hypersensitivity/Functional heartburn are common among non-erosive reflux disease (NERD) patients who do not response to proton pump inhibitors. Whether tricyclic antidepressant improves NERD patient's symptoms remains unknown
Aim of this randomized controlled trial study is to determine the efficacy of imipramine, which could increase esophageal pain thresholds in healthy volunteers, in comparison with placebo for treatment patients with esophageal hypersensitivity or functional heartburn evaluated by improvement of specific-symptom score and quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •patient with typical reflux symptoms (heartburn and/or regurgitation) more than 3 times per week in at least last 3 months
- •Age more than 18 years
- •Upper GI endoscopy showed no esophageal mucosal breaks
- •MII-pH monitoring was not showed abnormal both acid and non-acid reflux
- •symptoms was not improved after received standard dose proton pump inhibitor for at least 1 month
排除标准
- •history of thoracic, esophagus, or stomach surgery
- •severe esophageal motility disorder eg. Achalasia, scleroderma, autonomic/peripheral neuropathy/myopathy
- •patient who was indicated to receive proton pump inhibitor
- •pregnant women
- •patient who was allergy to imipramine
- •patient who received tricyclic antidepressant or SSRI with in 3 month of enrollment
研究组 & 干预措施
imipramine
Active Comparator
干预措施: imipramine (Drug)
结局指标
主要结局
improvement of GERD score
时间窗: 6 months
次要结局
- improve quality of life(6 months)
研究者
研究点 (1)
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