Gastroparesis
Conditions
Brief summary
To prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy.
Detailed description
The primary objective of this study is to prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy
Interventions
DRUGDomperidone
Domperidone will be prescribed for patients with upper GI symptoms at an initial dose of 10 mg up to 4 times a day (prior to each meal and at bedtime). It is possible that the dose of domperidone may be increased to 20 mg if symptoms are not adequately controlled on the initial dose.
Sponsors
Yale University
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females who are 18 years of age or older 2. Symptoms or manifestations secondary to Gastro esophageal reflux disease (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.
Exclusion criteria
1. i. 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. ii. Clinically significant bradycardia, sinus node dysfunction, or heart block. iii. Prolonged QTc (QTc\>450 milliseconds for males, QTc\>470 milliseconds for females) iv. Clinically significant electrolyte disorders. 2. Gastrointestinal hemorrhage or obstruction. 3. Presence of a prolactinoma (prolactin-releasing pituitary tumor). 4. Pregnant or breast feedings female. 5. Known allergy to domperidone
Countries
United States
Outcome results
None listed