Gastroparesis is a digestive disorder in which motility of the stomach is either slowedor absent. The gastroparesis prevents normal digestion from occurring. The purpose ofthis study is to provide oral Domperidone offered under the U.S. Food and DrugAdministration (FDA) expanded access program, to patients that, based on the treatingdoctor's assessment, could benefit from , a prokinetic effect for the relief ofrefractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms,gastroparesis, and chronic constipation.
At the discretion of the Investigator, 10-30 mg of oral domperidone is administered QID
(four times a day). The Investigator will be starting patients on 10 mg four times a day
for 2 weeks, then increase to 20 mg four times a day for 2 weeks. The participant will be
evaluated at each time point. If the participant still is not having relief of symptoms
the investigator may increase their dose to 30mg four times a day.
Drug: Oral Domperidone
10 mg of oral domperidone administered (four times a day) for two weeks
Drug: Oral Domperidone
Increased to 20 mg four times a day for 2 weeks at the Investigator's discretion
Drug: Oral Domperidone
Increased to 30 mg four times a day at the Investigator's discretion
Inclusion Criteria:
1. Male or female
2. Age 18 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 refractory to standard therapy.
4. Patients must have a comprehensive evaluation (physical exam and also may include
EGD, gastric emptying study, as clinically necessary) 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 including:
- increased prolactin levels
- extrapyramidal side-effects
- breast changes
- cardiac arrhythmias including QT prolongation and death
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.
1. Clinically significant bradycardia, sinus node dysfunction, or heart block.
Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females).
2. Clinically significant electrolyte disorders.
3. Gastrointestinal hemorrhage or obstruction
4. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
5. Pregnant or breast feeding female
6. Known allergy to domperidone
Eastern Regional Medical Center, Inc.
Philadelphia, Pennsylvania, United States
Investigator: Raman Battish, MD
Contact: 215-537-7400
Raman.Battish@ctca-hope.com
Raman Battish, MD
215-537-7400
Raman.Battish@ctca-hope.com
Jack Medendorp
215-537-3160
Jack.Medendorp@ctca-hope.com
Not Provided