RecruitingNot Applicable

Compassionate Use of Domperidone for Refractory Gastroparesis

United States20 participantsStarted 2013-04

Plain-language summary

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.

Who can participate

Age range12 Years – 21 Years

SexALL

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Inclusion criteria

✓. 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:

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 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

What they're measuring

Change in disease severity

Timeframe: Up to 1 year

Trial details

NCT IDNCT04699591

SponsorJose Cocjin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2035-12

Contact for this trial

Corey Schurman, MA, CCRC

816-302-3076 crschurman@cmh.edu

View on ClinicalTrials.gov More GERD trials