The Use of Domperidone for Gastroparesis

Individuals who have been diagnosed with gastroparesis and have failed at least one standard
therapy will be offered to trial domperidone as a possible remedy to their condition.
Patients on the medication will be expected to to be followed by the physician at 3 months,
6 months 12months, and then annually while on the medication. Any change or significant
adverse reaction to the medication or in their condition should be reported immediately to
their physician.

Inclusion Criteria:

1. Male or female

2. Age 18 or 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. Subjects must have a comprehensive evaluation to eliminate other causes of their
symptoms.

5. 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, and

Exclusion Criteria:

1. History of or current cardiac disease, including ischemic or valvular heart disease,
other structural heart defects, cardiomyopathy or congestive heart failure.

2. 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.

3. 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.

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

5. 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.)

6. Pregnant or breast feeding female.

7. Known allergy to domperidone or any components of the domperidone formulation.

8. Significantly significant electrolyte disorders.

9. Gastrointestinal hemorrhage or obstruction.