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Domperidone for Gastroparesis in Solid Organ Transplantation - NCT00552422-10032(Clinical Trial 189387)



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City:  New York
State:  
NY
Zip Code: 10032
Conditions: Gastroparesis - Gastroesophageal Reflux
Purpose: The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.
Study summary: After heart or lung transplantation, the stomach tends to empty much slower than normal. This slow emptying is called "gastroparesis." Gastroparesis is uncomfortable and often leads to nausea and vomiting. In addition to drastically impacting quality of life, severe nausea and vomiting can also lead to malnutrition and an inability to take oral medications, contributing to complications of transplantation. Treatments for gastroparesis include both medical and surgical therapies that work for some but not all patients. Domperidone is a peripheral D2 antagonist that improves the emptying of the stomach in patients with gastroparesis. Domperidone is not FDA approved at this time. Some patients have developed lifethreatening abnormal heart rhythms after receiving domperidone intravenously. This problem has not been seen with domperidone given by mouth. We propose to administer domperidone by mouth at standard doses to solid organ transplant patients who have gastroparesis that is not responsive to standard medical therapies or who experience adverse drug side effects. This study will not be blinded (open-label) and has a single treatment arm (no control or placebo group).
Criteria: Inclusion Criteria: - gastroparesis or gastroesophageal reflux that is refractory to standard therapy. - signed informed consent Exclusion Criteria: - serious cardiac arrhythmias - clinically significant bradycardia, sinus node dysfunction, or heart block. - prolonged QTc - clinically significant electrolyte disorders. - gastrointestinal hemorrhage or obstruction. - prolactinoma - pregnant or breast feeding female - known allergy to domperidone.
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Data Source: ClinicalTrials.gov
Date Processed: March 15, 2010
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