Actively Recruiting
Compassionate Use of Domperidone for Refractory Gastroparesis in Children and Young Adults
Led by Jose Cocjin · Updated on 2026-03-24
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to allow the use of domperidone in children and young adults aged 12 to 21 who have symptoms related to gastrointestinal motility disorders and Gastroesophageal Reflux Disease (GERD) that have not improved with standard treatments. The study focuses on people with symptoms such as persistent esophagitis, heartburn, nausea, vomiting, severe dyspepsia, or severe chronic constipation, all linked to these conditions. Participants will take domperidone four times daily, with the dose adjusted based on their weight. Before starting treatment, participants will undergo a medical history review, physical examination, ECG, blood tests, and pregnancy test if female to ensure safety. During the first year, physical exams, blood draws, and ECGs will occur every two months. After one year, if treatment is beneficial, these checks will continue every six months until the medication is stopped. Throughout the study, participants will have regular health assessments including heart and breathing rates, blood pressure, height, weight, and blood tests to monitor domperidone levels. ECGs will be performed to monitor heart function, especially if the dose increases. The main outcome measured is the change in disease severity over up to one year. The total study period extends until December 2035, allowing long-term monitoring.
CONDITIONS
Brief Title
Compassionate Use of Domperidone for Refractory Gastroparesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Age 12 to 21 years
- Symptoms related to GERD or gastrointestinal motility disorders such as persistent esophagitis, heartburn, nausea, vomiting, severe dyspepsia, or severe chronic constipation that are resistant to standard treatments
- Must have a thorough evaluation to rule out other possible causes of symptoms
- Signed informed consent acknowledging potential side effects including increased prolactin levels, extrapyramidal symptoms, breast changes, cardiac arrhythmias, and risks related to certain medications and supplements
You will not qualify if you...
- History or current presence of serious arrhythmias like ventricular tachycardia, ventricular fibrillation, or Torsade des Pointes
- Clinically significant bradycardia, sinus node dysfunction, or heart block; prolonged QTc interval
- Significant electrolyte imbalances
- Gastrointestinal bleeding or obstruction
- Presence of prolactinoma (pituitary tumor)
- Pregnant or breastfeeding females
- Known allergy to domperidone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year or longer if benefiting
Participants take domperidone four times per day with the dose calculated based on their weight.
Physical examination, blood draws, and ECG every 2 months for the first year; after the first year, these occur every 6 months if participants continue treatment. Additional ECGs occur when the dose is increased.
Trial Site Locations
Total: 1 location
1
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
Research Team
C
Corey Schurman, MA, CCRC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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