Treatment Use of Domperidone for Gastroparesis

The Treatment Use of Domperidone program is also available at the Cleveland Clinic
Florida/Weston Gastroenterology Department. This is not a "traditional" research study, but
an expanded use protocol for patients who may benefit from the drug. Because of this, this
study is enrolling patients via invitation only, and as such, all expenses associated with
the drug, initiation and follow up of treatment are the responsibility of the patient or the
patient's third party payer.

Inclusion Criteria:

- Male or female

- Age 18 and 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.

- Patients must have a comprehensive evaluation to eliminate other causes of their
symptoms.

- Patient has signed informed consent for the administration of domperidone that informs
the patient of potential adverse events including:

- increased prolactin levels

- extrapyramidal side effects

- breast changes

- cardiac arrhythmias including QT prolongation and death

- There is a potential for increased risk of adverse events with the drugs listed
in the domperidone protocol addendum.

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.

- Gastrointestinal hemorrhage or obstruction

- Presence of a prolactinoma (prolactin-releasing pituitary tumor).

- Pregnant or breast feeding female

- Known allergy to domperidone