NCT04699591 Compassionate Use of Domperidone for Refractory Gastroparesis
| NCT ID | NCT04699591 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jose Cocjin |
| Condition | GERD |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2013-04 |
| Primary Completion | 2035-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2013-04 with a primary completion date of 2035-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 failed all the standard treatments for their condition.
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
Contact & Investigator
Jose Cocjin, MD
PRINCIPAL INVESTIGATOR
Children's Mercy Hospital Kansas City
Frequently Asked Questions
Who can join the NCT04699591 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 21 Years, studying GERD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04699591 currently recruiting?
Yes, NCT04699591 is actively recruiting participants. Contact the research team at crschurman@cmh.edu for enrollment information.
Where is the NCT04699591 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT04699591 clinical trial?
NCT04699591 is sponsored by Jose Cocjin. The principal investigator is Jose Cocjin, MD at Children's Mercy Hospital Kansas City. The trial plans to enroll 20 participants.