Domperidone Expanded Access Protocol for Patients With Gastrointestinal Disorders

Expanded Access Program Design:

The purpose of the Expanded Access Program is to provide oral Domperidone to patients' ≥12
years of age where, according to the investigator's judgment, a prokinetic effect is needed
for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI)
symptoms, gastroparesis, and chronic constipation.

The objective of the Expanded Access Program is to allow the use of Domperidone by patients
with gastrointestinal disorders who have failed standard therapy. Failed standard therapy can
be constituted by the following treatments: PPI Therapy, Erythromycin, allergy to
medications. Subject must be on these therapies for a time period of 1 month before they are
considered to be ineffective.

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. Failed standard therapy can be constituted by
the following treatments: PPI Therapy, Erythromycin, allergy to medications. Subject
must be on these therapies for a time period of 1 month before they are considered to
be ineffective.

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

5. Patient or Parent/Legal Guardian has signed informed consent and child assent (as
appropriate) 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 (see Appendix).

6. Patients with a weight > 35kg

7. Patients are able to swallow the Domperidone pill.

Exclusion Criteria:

1. 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.

2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged
QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females).

3. Hepatic dysfunction

4. Renal insufficiency

5. Clinically significant electrolyte disorders.

6. Gastrointestinal hemorrhage or obstruction

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

8. Pregnant or breast feeding female

9. Known allergy to Domperidone

10. The use of medications that interact with Domperidone. a. Subjects may be required to
stop use (wash-out) of medications that interact with Domperidone. If the subject is
not willing or able to stop use of the interacting medication, they may be excluded or
withdrawn from the study at the investigator's discretion. Based on the medication the
subject may be required to stop-use or wash out from, the PI will determine the
appropriate washout period using clinical judgment. Some medications may require much
longer washout periods than others, and this will be explained to each respective
subject that requires stopping a medication.