Domperidone for Refractory Gastrointestinal Disorders

Status unconfirmed · Not applicable

Conditions studied: Gastroparesis

In brief

The purpose of this study is to prescribe oral domperidone for subjects with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.

Key facts

Study ID

NCT00777439

Run by

Arnold, George, M.D.

People needed

75

Starts

2008-10-01

Expected to finish

2018-01-01

Last updated by the study team

2016-08-18

Who can join

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

You may qualify if…

• Male or female
• Age 18 or 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 that are refractory to standard therapy.
• Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
• Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:
• increased prolactin levels
• extrapyramidal side effects
• breast changes
• cardiac arrhythmias including QT prolongation
• there is a potential for increased risk of adverse events with the drugs listed in the addendum

You may not qualify if…

• History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
• History of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
• Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
• Presence of a prolactinoma (prolactin-releasing pituitary tumor).
• Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo- obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
• Pregnant or breast feeding female.
• Known allergy to domperidone or any components of the domperidone formulation.
• Significantly significant electrolyte disorders.
• Gastrointestinal hemorrhage or obstruction.

Where it is running

• Division of Gastroenterology, Hepatology and Nutrition, UPMC Presbyterian Digesive Disorders Center, 3rd Floor, 200 Lothrop Street — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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