RECRUITING

Domperidone in Treating Patients With Gastrointestinal Disorders

Conditions

Digestive System Disorder Dyspepsia Esophagitis Gastroesophageal Reflux Disease Gastroparesis Heartburn Nausea and Vomiting

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Treatment Protocol for the Compassionate Use of Domperidone

Quick Facts

Study Start:2012-10-23

Study Completion:2025-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01696734

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Mehnaz Shafi

CONTACT

713-794-5073

mashafi@mdanderson.orgs

Principal Investigator

Mehnaz Shafi

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Mehnaz Shafi, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-10-23

Study Completion Date2025-10-31

Study Record Updates

Study Start Date2012-10-23

Study Completion Date2025-10-31

Terms related to this study

Additional Relevant MeSH Terms

Digestive System Disorder
Dyspepsia
Esophagitis
Gastroesophageal Reflux Disease
Gastroparesis
Heartburn
Nausea and Vomiting