Compassionate Use of Domperidone for Refractory Gastroparesis
Jose Cocjin
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.
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 a physical examination, including heart and breathing rates, blood pressure, height, weight, and an ECG. An ECG measures the electrical activity of the heart over a period of time. This is a non-invasive procedure and involves attaching sticky pads to your chest and recording your body's electrical activity on a machine. The study doctor/nurse will explain this in more detail to you. * You will h…
Eligibility
- Age range
- 12–21 years
- Sex
- All
- Healthy volunteers
- No
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: * increas…
Interventions
- DrugDomperidone
Domperidone taken 4 times a day, dose based on body weight
Location
- Children's Mercy Hospitals and ClinicsKansas City, Missouri