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 range12 Years
SexALL
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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:
✓. Patients with a weight \> 35kg
✓. 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).