NCT00760461终止2 期
Domperidone in Refractory Gastroparesis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Gastroparesis Cardinal Symptom Index
研究概览
简要总结
The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.
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
- •Male or female
- •Age 18 and older
- •Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
- •Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
- •Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
- •Increased prolactin levels
- •Breast changes
- •Extrapyramidal side effects
- •Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)
排除标准
- •History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients 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. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
- •Gastrointestinal hemorrhage or obstruction.
- •Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- •Pregnant or breast feedings female.
- •Known allergy to domperidone
研究组 & 干预措施
Domperidone
Other
干预措施: Domperidone (Drug)
结局指标
主要结局
Gastroparesis Cardinal Symptom Index
时间窗: upon study completion
次要结局
未报告次要终点
研究者
研究点 (1)
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