Domperidone in Treating Patients with Gastrointestinal Disorders

Inclusion Criteria:

• Patients with GI disorders who have failed standard therapy

• Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophagealreflux 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 physicalexamination, to eliminate other causes of their symptoms

• Patient has signed the informed consent document agreeing to the use of the studydrug, 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

Exclusion Criteria:

• Patients with the following cardiac diagnoses: ventricular tachycardia orfibrillation; Torsade des Pointes; clinically significant bradycardia; sinus nodedysfunction; heart block; prolonged QTc interval (QTc > 450 milliseconds for males,QTc > 470 milliseconds for females); prior specific cardiovascular conditions ofclinically significant valvular heart disease requiring medication, ischemic, orpulmonary heart disease; cardiomyopathy; history of heart failure

• Patients who are receiving antiarrhythmic medications with action on repolarizationtimes (with prolongation of the QTc interval such as amiodarone, disopyramide,dofetilide, flecainide, ibutilide, quinidine, sotalol, dronedarone etc.)

• Patients who are receiving monoamine oxidase (MAO) inhibitors

• Patients with a history of or active liver failure

• Clinically significant electrolyte disorders including sodium < 130 or > 145 and/orpotassium < 3.0 or > 5.5 and/or magnesium < 1.6 or > 2.6

• GI hemorrhage or obstruction experienced within the previous 6 weeks

• Presence of a prolactinoma (prolactin-releasing pituitary tumor)

• Pregnant or breast-feeding female (women of childbearing potential [WOCBP], definedas not post-menopausal for 12 months or without previous surgical sterilization,must have a negative urine pregnancy test within 30 days of the first administrationof domperidone and must either commit to continued abstinence from heterosexualintercourse or use an effective method of birth control during the course of thestudy)

• Known allergy to domperidone