To allow the use of domperidone by patients with gastrointestinal disorders who havefailed standard therapy.
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 in patients whom the potential benefit may outweigh the risk of
cardiovascular adverse reactions including QT prolongation, Torsades de Pointes, and
death.
Drug: Domperidone Oral Product
10-30 mg of oral domperidone administered QID.
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.
4. Patients must have a comprehensive evaluation to eliminate other causes of their
symptoms.
5. Patient has signed informed consent for the administration of domperidone that
informs the patient of potential adverse events
Exclusion Criteria:
History of, or current, arrhythmias including ventricular tachycardia, ventricular
fibrillation and Torsades de Pointes. Patients with minor forms of ectopy (PACs) are not
necessarily excluded.
1. Clinically significant bradycardia, sinus node dysfunction, or heart block.
Prolonged QTc (QTc > 450 milliseconds for males, QTc>470 milliseconds for females).
2. Hepatic dysfunction
3. Renal insufficiency
4. Clinically significant electrolyte disorders.
5. Gastrointestinal hemorrhage or obstruction
6. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
7. Pregnant or breast feeding female
8. Known allergy to domperidone
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Investigator: Devin Spaulding, BS
Contact: 920-288-3127
devin.spaulding@aah.org
Investigator: John J Bosco, MD
Devin Spaulding, BS
920-288-3127
devin.spaulding@aah.org
John Bosco, MD, Principal Investigator
Aurora BayCare Medical Center