Domperidone in Treating Patients With Gastrointestinal Disorders
Recruiting
Phase 3Interventional Study
Digestive System DisorderDyspepsiaEsophagitisGastroesophageal Reflux DiseaseGastroparesisHeartburnNausea and Vomiting
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
16 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Other
Participants needed
200 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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…
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
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