Domperidone in Refractory Gastroparesis

Stopped early · Phase 2

Conditions studied: Gastroparesis

In brief

The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.

Key facts

Study ID

NCT00760461

Run by

Yale University

People needed

44

Starts

2008-10-01

Expected to finish

2011-07-01

Last updated by the study team

2017-08-18

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 motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
• Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
• Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
• Increased prolactin levels
• Breast changes
• Extrapyramidal side effects
• Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)

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. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
• Gastrointestinal hemorrhage or obstruction.
• Presence of a prolactinoma (prolactin-releasing pituitary tumor).
• Pregnant or breast feedings female.
• Known allergy to domperidone

Where it is running

• Yale Digestive Diseases 40 Temple St, Suite 1A — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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