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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
Must not have
Gastrointestinal hemorrhage or obstruction
Presence of a prolactinoma (prolactin-releasing pituitary tumor)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I have severe GERD symptoms or stomach issues not relieved by standard treatments.
Select...
I am between 12 and 21 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had bleeding or blockage in my digestive tract.
Select...
I have a tumor in my pituitary gland that releases prolactin.
Select...
I have a slow heartbeat or heart rhythm issue, and my QTc interval is longer than normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in disease severity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
256 Previous Clinical Trials
940,315 Total Patients Enrolled
Jose Cocjin, MDPrincipal InvestigatorChildren's Mercy Hospital Kansas City
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any drugs or supplements listed as risky in the trial's addendum.I have noticed changes in my breast.I have side effects from medication that affect my body movements.I have signed a consent form understanding the risks of taking domperidone, including heart issues and breast changes.You have important problems with the minerals in your body.I have severe GERD symptoms or stomach issues not relieved by standard treatments.I have had bleeding or blockage in my digestive tract.I have a tumor in my pituitary gland that releases prolactin.I understand the risks of certain medications and supplements and will consult before using them.You are allergic to domperidone.I have a slow heartbeat or heart rhythm issue, and my QTc interval is longer than normal.I have a history of serious heart rhythm problems but not minor irregular heartbeats.I have severe GERD symptoms or stomach issues not relieved by standard treatments.Before joining the study, patients need to undergo a thorough examination to rule out other reasons for their symptoms.I am between 12 and 21 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Overall Study
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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