The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms
- Conditions
- Gastroparesis
- Registration Number
- NCT03810287
- Lead Sponsor
- Yale University
- Brief Summary
To prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy.
- Detailed Description
The primary objective of this study is to prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- Males or females who are 18 years of age or older
- Symptoms or manifestations secondary to Gastro esophageal 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.
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i. 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.
ii. Clinically significant bradycardia, sinus node dysfunction, or heart block.
iii. Prolonged QTc (QTc>450 milliseconds for males, QTc>470 milliseconds for females)
iv. Clinically significant electrolyte disorders.
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Gastrointestinal hemorrhage or obstruction.
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Presence of a prolactinoma (prolactin-releasing pituitary tumor).
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Pregnant or breast feedings female.
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Known allergy to domperidone
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Yale Digestive Diseases
🇺🇸New Haven, Connecticut, United States