An Investigational New Drug Program for the Use of Domperidone in the Treatment of Refractory Gastroesophageal Reflux Disease and Other Gastrointestinal Motility Disorders
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Improvement of symptoms for patients with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.
研究概览
简要总结
The purpose of this study is to prescribe oral domperidone for subjects with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.
详细描述
Domperidone is a dopamine-2 receptor antagonist. It acts as a prokinetic agent through its effects on the chemoreceptor trigger zone and the motor function of the stomach and small intestines. It does not cause any adverse neurological symptoms and has an excellent safety profile for long-term oral administration in recommended doses.
In the United States, domperidone is not approved by the Food and Drug Administration (FDA) and cannot be obtained by routine prescriptions or covered by health care insurance plans. It is also illegal to write a prescription for the subject to obtain the drug outside the U.S. Domperidone can be administered legally by obtaining a FDA Investigational New Drug (IND) application with Institutional Review Board (IRB) approval.
This study will follow FDA and IRB regulations and provide domperidone to subjects with gastrointestinal disorders who have failed from standard 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 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 are refractory to standard therapy.
- •Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
- •Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:
- •increased prolactin levels
- •extrapyramidal side effects
- •breast changes
- •cardiac arrhythmias including QT prolongation
- •there is a potential for increased risk of adverse events with the drugs listed in the addendum
排除标准
- •History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
- •History of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
- •Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
- •Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- •Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo- obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
- •Pregnant or breast feeding female.
- •Known allergy to domperidone or any components of the domperidone formulation.
- •Significantly significant electrolyte disorders.
- •Gastrointestinal hemorrhage or obstruction.
研究组 & 干预措施
Domperidone
All eligible subjects will receive domperidone in an open label, single group assignment.
干预措施: Domperidone (Drug)
结局指标
主要结局
Improvement of symptoms for patients with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.
时间窗: Domperidone will be prescrided as long as patients benefit from taking it.
次要结局
未报告次要终点
研究者
George Arnold, MD
Principal Investigator
Arnold, George, M.D.