Domperidone in Refractory Gastroparesis



Status:Terminated
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:8/19/2017
Start Date:October 2008
End Date:July 2011

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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.


Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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
We found this trial at
1
site
40 Temple Street
New Haven, Connecticut 06510
?
mi
from
New Haven, CT
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