Treatment Use of Domperidone for Gastroparesis



Status:Available
Conditions:Gastroesophageal Reflux Disease , Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Contact:Caroline Matyas
Email:matyasc@ccf.org
Phone:216-444-2084

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Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux
disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation.

This is a long-term treatment program for prescription of this drug to all patients who, in
the investigators' judgement, could benefit from its use.

The Treatment Use of Domperidone program is also available at the Cleveland Clinic
Florida/Weston Gastroenterology Department. This is not a "traditional" research study, but
an expanded use protocol for patients who may benefit from the drug. Because of this, this
study is enrolling patients via invitation only, and as such, all expenses associated with
the drug, initiation and follow up of treatment are the responsibility of the patient or the
patient's third party payer.

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 motility
disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation
that are refractory to standard therapy.

- Patients must have a comprehensive evaluation 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

- There is a potential for increased risk of adverse events with the drugs listed
in the domperidone protocol addendum.

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.

- Gastrointestinal hemorrhage or obstruction

- Presence of a prolactinoma (prolactin-releasing pituitary tumor).

- Pregnant or breast feeding female

- Known allergy to domperidone
We found this trial at
2
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-6523
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Phone: 954-659-5646
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Weston, FL
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