NCT04699591

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
117mo left

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Apr 2013Dec 2035

Study Start

First participant enrolled

April 1, 2013

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

22.7 years

First QC Date

December 28, 2020

Last Update Submit

March 20, 2026

Conditions

GERDGastroparesisGastroesophageal Reflux

Keywords

refluxacid reflux

Outcome Measures

Primary Outcomes (1)

  • Change in disease severity

    refractory gastroparesis or GERD(Gastroesophageal Reflux Disease)

    Up to 1 year

Study Arms (1)

Overall Study

OTHER

Receive domperidone 4 times a day, weight-dependent dose

Drug: Domperidone

Interventions

DomperidoneDRUG

Domperidone taken 4 times a day, dose based on body weight

Also known as: Motilium, Motillium, Motinorm Costi, Nomit, Brulium, Molax
Overall Study

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male or female
  • Age 12 - 21
  • 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.
  • Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
  • 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.

You may not qualify if:

  • 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.
  • Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged Tc (QTc\> 450 milliseconds for males, QTc\>470 milliseconds for females).
  • Clinically significant electrolyte disorders.
  • Gastrointestinal hemorrhage or obstruction
  • Presence of a prolactinoma (prolactin-releasing pituitary tumor).
  • Pregnant or breast feeding female
  • Known allergy to domperidone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

RECRUITING

MeSH Terms

Conditions

Gastroesophageal RefluxGastroparesis

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jose Cocjin, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Corey Schurman, MA, CCRC

CONTACT

816-302-3076crschurman@cmh.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Physician

Study Record Dates

First Submitted

December 28, 2020

First Posted

January 7, 2021

Study Start

April 1, 2013

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

US(1)