Compassionate Use of Domperidone for Refractory Gastroparesis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorJose Cocjin
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Domperidone
DrugDomperidone taken 4 times a day, dose based on body weight
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Overall StudyOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in disease severity
refractory gastroparesis or GERD(Gastroesophageal Reflux Disease)
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jose Cocjin
Lead sponsor
Children's Mercy Hospital Kansas City
Sponsor institution
Source ClinicalTrials.gov