Domperidone for Gastroparesis Associated With Solid Organ Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Symptomatic Improvement
研究概览
简要总结
The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.
详细描述
After heart or lung transplantation, the stomach tends to empty much slower than normal. This slow emptying is called "gastroparesis." Gastroparesis is uncomfortable and often leads to nausea and vomiting. In addition to drastically impacting quality of life, severe nausea and vomiting can also lead to malnutrition and an inability to take oral medications, contributing to complications of transplantation. Treatments for gastroparesis include both medical and surgical therapies that work for some but not all patients.
Domperidone is a peripheral D2 antagonist that improves the emptying of the stomach in patients with gastroparesis. Domperidone is not FDA approved at this time. Some patients have developed lifethreatening abnormal heart rhythms after receiving domperidone intravenously. This problem has not been seen with domperidone given by mouth.
We propose to administer domperidone by mouth at standard doses to solid organ transplant patients who have gastroparesis that is not responsive to standard medical therapies or who experience adverse drug side effects. This study will not be blinded (open-label) and has a single treatment arm (no control or placebo group).
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
- None
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
- •gastroparesis or gastroesophageal reflux that is refractory to standard therapy.
- •signed informed consent
排除标准
- •serious cardiac arrhythmias
- •clinically significant bradycardia, sinus node dysfunction, or heart block.
- •prolonged QTc
- •clinically significant electrolyte disorders.
- •gastrointestinal hemorrhage or obstruction.
- •prolactinoma
- •pregnant or breast feeding female
- •known allergy to domperidone.
研究组 & 干预措施
Domperidone Arm
Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with significant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with significant renal impairment will be 20mg twice a day.
干预措施: domperidone (Drug)
结局指标
主要结局
Symptomatic Improvement
时间窗: 2 months
The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.
次要结局
未报告次要终点
研究者
David J. Lederer, M.D.
Herbert Irving Assistant Professor of Medicine and Epidemiology
Columbia University
