The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms

Status:

NO_LONGER_AVAILABLE

The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms

Lead Sponsor:

Yale University

Conditions:

Gastroparesis

Eligibility:

All Genders

18+ years

Brief Summary

To prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy.

Detailed Description

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

Eligibility Criteria

Inclusion

Males or females who are 18 years of age or older
Symptoms or manifestations secondary to Gastro esophageal reflux disease (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.

Exclusion

i. 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.
ii. Clinically significant bradycardia, sinus node dysfunction, or heart block.
iii. Prolonged QTc (QTc\>450 milliseconds for males, QTc\>470 milliseconds for females)
iv. Clinically significant electrolyte disorders.
Gastrointestinal hemorrhage or obstruction.
Presence of a prolactinoma (prolactin-releasing pituitary tumor).
Pregnant or breast feedings female.
Known allergy to domperidone

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03810287

Last Update

March 5 2025

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