Domperidone Expanded Access Protocol for Patients With Gastrointestinal Disorders

Inclusion Criteria:

1. Male or female

2. Age 12 and older

3. Symptoms or manifestations secondary to gastroesophageal reflux disease (GERD) (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms orrespiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting,severe dyspepsia or severe chronic constipation that are refractory to standardtherapy. Failed standard therapy can be constituted by the following treatments: PPITherapy, Erythromycin, allergy to medications. Subject must be on these therapiesfor 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 theirsymptoms.

5. Patient or Parent/Legal Guardian has signed informed consent and child assent (asappropriate) for the administration of Domperidone that informs the patient ofpotential 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 listedin 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, ventricularfibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) arenot 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 requiredto stop use (wash-out) of medications that interact with Domperidone. If the subjectis not willing or able to stop use of the interacting medication, they may beexcluded or withdrawn from the study at the investigator's discretion. Based on themedication the subject may be required to stop-use or wash out from, the PI willdetermine the appropriate washout period using clinical judgment. Some medicationsmay require much longer washout periods than others, and this will be explained toeach respective subject that requires stopping a medication.