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Dopamine Antagonist

Domperidone for Gastroparesis and Acid Reflux

N/A
Recruiting
Led By Jose Cocjin, MD
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Male or female aged 12 - 21
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial program will allow the use of domperidone in children with motility disorders and GERD who have failed standard treatments.

Who is the study for?
This trial is for children and young adults aged 12-21 with severe symptoms of GERD or gastroparesis that haven't improved with standard treatments. They must understand the risks, including heart issues and hormonal changes, and not be pregnant, breastfeeding, or have certain heart conditions or allergies to domperidone.Check my eligibility
What is being tested?
Domperidone is being used compassionately for those who have not responded to typical therapies for motility disorders like gastroparesis and GERD-related symptoms. The trial aims to provide relief from nausea, vomiting, and other digestive problems.See study design
What are the potential side effects?
Possible side effects include increased levels of a hormone called prolactin which can lead to breast changes; movement disorders; heart rhythm problems such as QT prolongation; and potential interactions with specific drugs and herbal supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe GERD symptoms or stomach issues not relieved by standard treatments.
Select...
I am between 12 and 21 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in disease severity

Trial Design

1Treatment groups
Experimental Treatment
Group I: Overall StudyExperimental Treatment1 Intervention
Receive domperidone 4 times a day, weight-dependent dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Domperidone
2011
Completed Phase 4
~401020

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
245 Previous Clinical Trials
935,779 Total Patients Enrolled
Jose Cocjin, MDPrincipal InvestigatorChildren's Mercy Hospital Kansas City

Media Library

Domperidone (Dopamine Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04699591 — N/A
Gastroparesis Research Study Groups: Overall Study
Gastroparesis Clinical Trial 2023: Domperidone Highlights & Side Effects. Trial Name: NCT04699591 — N/A
Domperidone (Dopamine Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04699591 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions are usually treated using this therapeutic approach?

"This treatment is chiefly applied to address upper gastrointestinal motility disorders. Additionally, it has been administered to patients with esophagitis, gastroesophageal reflux disease and gastroparesis."

Answered by AI

Does this experiment accept participants aged thirty years or younger?

"According to the inclusion criteria, only those between 12 and 21 are eligible for participation. Furthermore, there are 19 trials aimed at minors while 90 trials focus on senior citizens."

Answered by AI

What is the uppermost limit of participants in this experiment?

"Affirmative. Per the information found on clinicaltrials.gov, this research study is actively recruiting individuals as of May 17th 2022 and first began doing so on April 1st 2013. Currently they are enrolling 20 patients at a single location."

Answered by AI

Are there still vacancies for this experiment in medicine?

"According to the data available at clinicaltrials.gov, this medical study is actively searching for qualified volunteers since it was first made public on April 1st 2013 and last updated on May 17th 2022."

Answered by AI

Have any prior experiments been conducted to investigate this therapy?

"Currently, four studies are underway attempting to assess this remedy. One of the inquiries is presently in its third stage. While most investigations into this therapy take place in Bangkok, there are 4 separate sites running experiments with it."

Answered by AI

Does my profile fulfill the criteria for participation in this experiment?

"In order to be eligible for this medical trial, patients must fall between the ages of 12 and 21 and have been diagnosed with gastroesophageal reflux. Altogether, 20 individuals are being recruited in total."

Answered by AI

Who else is applying?

What state do they live in?
Arkansas
What portion of applicants met pre-screening criteria?
Did not meet criteria
~10 spots leftby Dec 2035