Treatment Protocol for the Compassionate Use of Domperidone
This phase III trial studies how well domperidone works in treating patients with gastrointestinal disorders. Domperidone may help control chronic gastrointestinal disorders and their symptoms, such as pain, bloating, and nausea and vomiting, by stimulating contraction of the stomach to increase its ability to empty itself of food.
• Patients with GI disorders who have failed standard therapy
• Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux disease (GERD) including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms; or c) severe dyspepsia
• Completion of a comprehensive evaluation, including clinical history and physical examination, to eliminate other causes of their symptoms
• Patient has signed the informed consent document agreeing to the use of the study drug, domperidone
• White blood cell (WBC) with differential greater than 3,000/ml
• Alkaline phosphatase less than 1.5 x upper limit of normal
• Alanine aminotransferase (ALT) less than 2 x upper limit of normal
• Aspartate aminotransferase (AST) less than 2 x upper limit of normal
• Bilirubin less than or equal to 2 x upper limit of normal
• Blood urea nitrogen (BUN) less than 2 x upper limit of normal
• Creatinine less than 1.5 x upper limit of normal
• Stable hemoglobin greater than or equal to 8.0 g/dl
• Potassium between range of 3.0 to 5.5
• Magnesium level between 1.6-2.6 mg