RECRUITING

Compassionate Use of Domperidone for Refractory Gastroparesis

Conditions

GERD Gastroesophageal Reflux Gastroparesis reflux acid reflux

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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

The purpose of this program is to allow the use of domperidone in children from 12 to 21 years of age with symptoms related to motility disorders and Gastroesophageal reflux disease (GERD) who have failed all the standard treatments for their condition.

Official Title

Compassionate Use of Domperidone for Refractory Gastroparesis

Quick Facts

Study Start:2013-04

Study Completion:2035-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04699591

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:12 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female 2. Age 12 - 21 3. Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy. 4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. 5. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including: * increased prolactin levels * extrapyramidal side effects * breast changes * Cardiac arrhythmias including QT prolongation * There is a potential for increased risk of adverse events with the drugs and herbal supplements listed in the addendum (See Addendum on pages 24 and 25) * The coordinator/investigator will have a discussion with the family about the use of any of the medications and herbal supplements listed in the addendum to make sure they understand the increased risk of their use and the need to contact the investigators prior to using any of the listed medications and herbal supplements.	1. History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded. 2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged Tc (QTc\> 450 milliseconds for males, QTc\>470 milliseconds for females). 3. Clinically significant electrolyte disorders. 4. Gastrointestinal hemorrhage or obstruction 5. Presence of a prolactinoma (prolactin-releasing pituitary tumor). 6. Pregnant or breast feeding female 7. Known allergy to domperidone

Inclusion Criteria

Exclusion Criteria

1. Male or female
2. Age 12 - 21
3. Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
5. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
* increased prolactin levels
* extrapyramidal side effects
* breast changes
* Cardiac arrhythmias including QT prolongation
* There is a potential for increased risk of adverse events with the drugs and herbal supplements listed in the addendum (See Addendum on pages 24 and 25)
* The coordinator/investigator will have a discussion with the family about the use of any of the medications and herbal supplements listed in the addendum to make sure they understand the increased risk of their use and the need to contact the investigators prior to using any of the listed medications and herbal supplements.

1. History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged Tc (QTc\> 450 milliseconds for males, QTc\>470 milliseconds for females).
3. Clinically significant electrolyte disorders.
4. Gastrointestinal hemorrhage or obstruction
5. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
6. Pregnant or breast feeding female
7. Known allergy to domperidone

Contacts and Locations

Study Contact

Corey Schurman, MA, CCRC

CONTACT

816-302-3076

crschurman@cmh.edu

Principal Investigator

Jose Cocjin, MD

PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Study Locations (Sites)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

United States

Collaborators and Investigators

Sponsor: Children's Mercy Hospital Kansas City

Jose Cocjin, MD, PRINCIPAL_INVESTIGATOR, Children's Mercy Hospital Kansas City

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 Date2013-04

Study Completion Date2035-12

Study Record Updates

Study Start Date2013-04

Study Completion Date2035-12

Terms related to this study

Keywords Provided by Researchers

reflux
acid reflux

Additional Relevant MeSH Terms

GERD
Gastroesophageal Reflux
Gastroparesis