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Domperidone in Refractory Gastroparesis - NCT00760461-06510(Clinical Trial 243377)



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City:  New Haven
State:  
CT
Zip Code: 06510
Conditions: Gastroparesis
Purpose: The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.
Study summary:
Criteria: Inclusion Criteria: - Male or female - Age 18 and older - Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy. - Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level. - Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including: - Increased prolactin levels - Breast changes - Extrapyramidal side effects - Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix) 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) - Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities. - Gastrointestinal hemorrhage or obstruction. - Presence of a prolactinoma (prolactin-releasing pituitary tumor). - Pregnant or breast feedings female. - Known allergy to domperidone
Study is available at: Yale Digestive Diseases 40 Temple St, Suite 1A
New Haven, CT 06510
United States

Primary Contact:
Anish Sheth
Email: anish.sheth@yale.edu
Phone: 203-785-4138

Secondary Contact:
Anish Sheth
Email: anish.sheth@yale.edu
Phone: 203-785-4138
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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