Gastroesophageal Reflux Clinical Trial
Official title:
Domperidone Expanded Access Protocol for Patients With Gastrointestinal Disorders
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.
Expanded Access Program Design: The purpose of the Expanded Access Program is to provide oral Domperidone to patients' ≥12 years of age where, according to the investigator's judgment, a prokinetic effect is needed for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation. The objective of the Expanded Access Program is to allow the use of Domperidone by patients with gastrointestinal disorders who have failed standard therapy. Failed standard therapy can be constituted by the following treatments: Proton Pump Inhibitor (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. ;
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