Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Relief for patients with gastrointestinal disorders who have failed standard therapy
研究概览
简要总结
The purpose of this study is to make Domperidone available to patients with gastrointestinal disorders who have failed standard therapy and who might benefit from it.
详细描述
Domperidone is the only medication that is a true prokinetic with a low percentage of side effects that is useful in the treatment of certain GI conditions, including gastroparesis and other motility disorders.
According to recent regulations, writing prescriptions for subject to obtain domperidone outside the United States has been determined to be illegal and the FDA has issued warnings against pharmacies compounding domperidone. The legal way of administering domperidone is by obtaining an Investigational New Drug Application.
This study is an effort to both follow federal regulations and provide the medication to subjects who would benefit from it where standard therapy has failed.
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
- •18 years or older
- •symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms, gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that is refractory to standard therapy
- •subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
排除标准
- •history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, and Torsade de pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
- •clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females.)
- •clinically significant electrolyte disorders.
- •gastrointestinal hemorrhage or obstruction.
- •presence of a prolactinoma (prolactin-releasing pituitary tumor.)
- •pregnant or breast feeding female.
- •known allergy to Domperidone.
结局指标
主要结局
Relief for patients with gastrointestinal disorders who have failed standard therapy
时间窗: As long as the subjects continue to take Domperidone.
次要结局
未报告次要终点