Treatment Use of Domperidone for Gastroparesis

Status:

NO_LONGER_AVAILABLE

Treatment Use of Domperidone for Gastroparesis

Lead Sponsor:

Scott Gabbard, MD

Conditions:

Gastroesophageal Reflux Disease

GERD

Eligibility:

All Genders

18+ years

Brief Summary

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...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT02227927

Last Update

June 29 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

Cleveland Clinic Florida

Weston, Florida, United States, 33331