Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy

Available (expanded access)

Conditions studied: Oncology Patients With Gastroparesis

In brief

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.

Key facts

Study ID

NCT02494687

Run by

Eastern Regional Medical Center

Last updated by the study team

2020-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female
• Age 18 and older
• 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.
• 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.
• 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

You may not qualify if…

• 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.
• Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females).
• Clinically significant electrolyte disorders.
• Gastrointestinal hemorrhage or obstruction
• Presence of a prolactinoma (prolactin-releasing pituitary tumor).
• Pregnant or breast feeding female
• Known allergy to domperidone

Where it is running

• Eastern Regional Medical Center, Inc. — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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