Status:
RECRUITING
Compassionate Use of Domperidone for Refractory Gastroparesis
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
GERD
Gastroesophageal Reflux
Eligibility:
All Genders
12-21 years
Phase:
NA
Brief 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 fa...
Detailed Description
The following will need to be completed before the investigational treatment can begin: * Your medical history will be reviewed to make sure domperidone is a safe option for treatment * You will have...
Eligibility Criteria
Inclusion
- 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.
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 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2035
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04699591
Start Date
April 1 2013
End Date
December 1 2035
Last Update
September 25 2025
Active Locations (1)
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1
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108