Domperidone in Refractory Gastroparesis

This is an interventional treatment trial for Gastroparesis Read More

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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