Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy
Gastroparesis is a digestive disorder in which motility of the stomach is either slowed or absent. The gastroparesis prevents normal digestion from occurring. The purpose of this study is to provide oral Domperidone offered under the U.S. Food and Drug Administration (FDA) expanded access program, to patients that, based on the treating doctor's assessment, could benefit from , a prokinetic effect for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation.
Study Start Date
Estimated Completion Date
- Drug: Oral Domperidone
- Internal Medicine: Gastroenterology,Hematology/Oncology
- Nursing: Gastroenterology,Hematology/Oncology
- Gastroenterology: GI Motility
- Family Medicine: Gastroenterology
- Oncology: Pharmacology/Therapy
- Physician Assistant: Gastroenterology,Hematology/Oncology
- Digestive System Diseases
Eastern Regional Medical Center -- EP2014022
Eastern Regional Medical Center
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
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
History of, or current, arrhythmias including ventricular tachycardia, ventricular
fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not
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
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
|Eastern Regional Medical Center Inc - Philadelphia, Pennsylvania||127.9 miles||Raman Battish MD||215-537-7400||Raman.Battish@ctca-hope.com|