Compassionate Use of Domperidone for Refractory Gastroparesis

Recruiting now · Not applicable

Conditions studied: GERD, Gastroesophageal Reflux, Gastroparesis

In brief

The purpose of this program is to allow the use of domperidone in children from 12 to 21 years of age with symptoms related to motility disorders and Gastroesophageal reflux disease (GERD) who have failed all the standard treatments for their condition.

Key facts

Study ID

NCT04699591

Run by

Jose Cocjin

People needed

20

Starts

2013-04-01

Expected to finish

2035-12-01

Last updated by the study team

2026-03-24

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female
• Age 12 - 21
• 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
• There is a potential for increased risk of adverse events with the drugs and herbal supplements listed in the addendum (See Addendum on pages 24 and 25)
• The coordinator/investigator will have a discussion with the family about the use of any of the medications and herbal supplements listed in the addendum to make sure they understand the increased risk of their use and the need to contact the investigators prior to using any of the listed medications and herbal supplements.

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 Tc (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

Where it is running

• Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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