Compassionate Use of Domperidone for Refractory Gastroparesis

Launched by CHILDREN'S MERCY HOSPITAL KANSAS CITY · Jan 5, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the use of a medication called domperidone for young people aged 12 to 21 who have severe symptoms related to conditions like gastroparesis and gastroesophageal reflux disease (GERD). These patients have not found relief from standard treatments, and the trial aims to provide them with an alternative option. To participate, individuals must have been thoroughly evaluated to rule out other causes for their symptoms and must be experiencing issues like persistent heartburn, nausea, or severe constipation.

Participants in this trial will need to sign consent forms that explain the potential risks of using domperidone, which can include increased levels of a hormone called prolactin, heart rhythm changes, and other side effects. It's important for families to know that the study team will discuss any other medications or supplements the participant is taking to ensure their safety. Since the trial is currently recruiting participants, families interested in this option should consult with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female
• • 2. Age 12 - 21
• • 3. 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.
• • 4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
• 5. 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 Criteria:
• • 1. 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.
• • 2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged Tc (QTc\> 450 milliseconds for males, QTc\>470 milliseconds for females).
• • 3. Clinically significant electrolyte disorders.
• • 4. Gastrointestinal hemorrhage or obstruction
• • 5. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
• • 6. Pregnant or breast feeding female
• • 7. Known allergy to domperidone