Domperidone in Treating Patients With Gastrointestinal Disorders

  • STATUS
    Recruiting
  • days left to enroll
    43
  • participants needed
    200
  • sponsor
    M.D. Anderson Cancer Center
Updated on 24 January 2021
nausea and vomiting
nausea
bloating
gastrointestinal disorder
dyspepsia
heartburn
gastroesophageal reflux
reflux
domperidone
potassium
urea
respiratory symptoms
vomiting
gastroesophageal reflux disease
asat
blood urea nitrogen
esophagitis
gastrointestinal disorders
acidity
gastrointestinal disease
gastric disorder
gastroparesis
magnesium level

Summary

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.

Description

PRIMARY OBJECTIVES:

I. To provide treatment with domperidone to patients >= 16 years of age where, according to the investigators' judgment, a prokinetic effect is needed for the relief of gastrointestinal (GI) motility disorders.

OUTLINE

Patients receive domperidone orally (PO) thrice daily (TID) or four times daily (QID). Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for at least 30 days.

Details
Condition Gastroenteritis, Gastroparesis, Gastroesophageal Reflux, GASTROINTESTINAL DISORDER, Dyspepsia, Digestive System Disease, Heartburn, Gastropathy, Esophagitis, Stomach Discomfort, Gastroesophageal Reflux Disease (GERD), Gastrointestinal Diseases and Disorders, Diabetic Gastroparesis, Nausea and Vomiting, Heartburn (Pediatric), Non-Ulcer Dyspepsia (NUD), gastroesophageal reflux disease, esophageal reflux, gerd, gastric reflux, gastro-oesophageal reflux, delayed gastric emptying, gastric atony, acidity, nausea/vomiting, gastrointestinal diseases, gastrointestinal disorders, gastrointestinal disease, digestive disorders, digestive diseases, digestive disorder, digestive disease
Treatment questionnaire administration, Questionnaires, Domperidone, Phone Calls
Clinical Study IdentifierNCT01696734
SponsorM.D. Anderson Cancer Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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; Torsades de pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged corrected QT (QTc) interval (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females); valvular, 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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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