Phase
Condition
Neoplasms
Gastroparesis
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 motilitydisorders such as nausea, vomiting, severe dyspepsia or severe chronic constipationrefractory 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 theirsymptoms.
Patient has signed informed consent for the administration of domperidone that informsthe patient of potential adverse events including:
increased prolactin levels
extrapyramidal side-effects
breast changes
cardiac arrhythmias including QT prolongation and death
Exclusion
Exclusion Criteria: History of, or current, arrhythmias including ventricular tachycardia, ventricularfibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are notnecessarily excluded.
Clinically significant bradycardia, sinus node dysfunction, or heart block. ProlongedQTc (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
Study Design
Study Description
Connect with a study center
Eastern Regional Medical Center, Inc.
Philadelphia, Pennsylvania 19124
United StatesPlanned
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