Domperidone Protocol - FDA Expanded Access Program

17-123 (16-817)

To allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy.

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Inclusion Criteria: 1. Male or female 2. Age 12 and older 3. 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. 4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. 5. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events Exclusion Criteria: History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded. 1. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc \> 450 milliseconds for males, QTc\>470 milliseconds for females). 2. Hepatic dysfunction 3. Renal insufficiency 4. Clinically significant electrolyte disorders. 5. Gastrointestinal hemorrhage or obstruction 6. Presence of a prolactinoma (prolactin-releasing pituitary tumor). 7. Pregnant or breast feeding female 8. Known allergy to domperidone

{'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}}

2024-03-01