Domperidone in Treating Patients With Gastrointestinal Disorders

Launched by M.D. ANDERSON CANCER CENTER · Sep 27, 2012

Keywords

ClinConnect Summary

This clinical trial is studying a medication called domperidone to see how well it works in treating various gastrointestinal (GI) disorders, such as chronic nausea, heartburn, and issues with food moving through the stomach. The goal is to help patients who have not found relief from other treatments. By taking domperidone, patients may experience less pain and discomfort as it helps the stomach empty more effectively.

To be eligible for this trial, participants should have specific GI disorders that have not responded to standard treatments and have completed a thorough medical evaluation to rule out other causes for their symptoms. This includes individuals experiencing severe heartburn, persistent esophagitis, or gastroparesis, among other issues. Participants will need to provide their consent to take domperidone and meet certain health criteria, including acceptable blood test results. During the trial, participants will closely monitor their symptoms and overall health to evaluate how well the medication works for them. It's also important to note that certain patients with specific heart or liver conditions, or those who are pregnant or breastfeeding, won't be eligible to participate in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Patients with the following cardiac diagnoses: ventricular tachycardia or fibrillation; Torsade des Pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged QTc interval (QTc \> 450 milliseconds for males, QTc \> 470 milliseconds for females); prior specific cardiovascular conditions of clinically significant valvular heart disease requiring medication, ischemic, or pulmonary heart disease; cardiomyopathy; history of heart failure
• • Patients who are receiving antiarrhythmic medications with action on repolarization times (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/or potassium \< 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 \[WOCBP\], defined as not post-menopausal for 12 months or without previous surgical sterilization, must have a negative urine pregnancy test within 30 days of the first administration of domperidone and must either commit to continued abstinence from heterosexual intercourse or use an effective method of birth control during the course of the study)
• • Known allergy to domperidone