Domperidone Expanded Access Protocol for Patients With Gastrointestinal Disorders (NCT02567175) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Domperidone Expanded Access Protocol for Patients With Gastrointestinal Disorders
United States
Plain-language summary
FDA currently allows patients 12 years of age and older with various gastrointestinal (GI) conditions to be treated with Domperidone through the Expanded Access to Investigational Drugs program. These conditions include gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients must have failed standard therapies to be eligible to receive Domperidone. This program facilitates availability of investigational drugs, (such as Domperidone) to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient's disease or condition.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female
. Age 12 and older
. Symptoms or manifestations secondary to gastroesophageal reflux disease (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. Failed standard therapy can be constituted by the following treatments: PPI Therapy, Erythromycin, allergy to medications. Subject must be on these therapies for a time period of 1 month before they are considered to be ineffective.
. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
. Patient or Parent/Legal Guardian has signed informed consent and child assent (as appropriate) for the administration of Domperidone that informs the patient of potential adverse events including:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients are able to swallow the Domperidone pill.
Exclusion criteria
. 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 QTc (QTc\> 450 milliseconds for males, QTc\>470 milliseconds for females).
. Hepatic dysfunction
. Renal insufficiency
. Clinically significant electrolyte disorders.
. Gastrointestinal hemorrhage or obstruction
. Presence of a prolactinoma (prolactin-releasing pituitary tumor).