- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04699591
Compassionate Use of Domperidone for Refractory Gastroparesis
July 14, 2023 updated by: Jose Cocjin, Children's Mercy Hospital Kansas City
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The following will need to be completed before the investigational treatment can begin:
- Your medical history will be reviewed to make sure domperidone is a safe option for treatment
- You will have a physical examination, including heart and breathing rates, blood pressure, height, weight, and an ECG. An ECG measures the electrical activity of the heart over a period of time. This is a non-invasive procedure and involves attaching sticky pads to your chest and recording your body's electrical activity on a machine. The study doctor/nurse will explain this in more detail to you.
- You will have up to 3 teaspoons of blood drawn through a needle in the arm to make sure it is safe for you to receive domperidone.
- You will have a pregnancy test if you are female.
If your tests results are acceptable, the following will happen to you:
- You will take domperidone 4 times per day. The dose will be calculated by your doctor according to your weight.
- Every two months for the first year, you will have a physical examination, including heart and breathing rates, blood pressure, height, weight, up to 3 teaspoons of blood drawn through a needle in your arm to measure blood levels, and an ECG.
- You will also have an ECG anytime there is an increase in the amount of domperidone you are taking.
- After the first year, if you are benefitting from taking domperidone you will have a physical examination, blood draw and ECG every six months until you stop taking domperidone.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Corey Schurman, MA, CCRC
- Phone Number: 816-302-3076
- Email: crschurman@cmh.edu
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Recruiting
- Children's Mercy Hospitals and Clinics
-
Contact:
- Corey Schurman, MA
- Phone Number: 816-802-1167
- Email: crschurman@cmh.edu
-
Contact:
- Jose Cocjin, MD
- Phone Number: 816-302-3400
- Email: jcocjin@cmh.edu
-
Principal Investigator:
- Jose Cocjin, MD
-
Sub-Investigator:
- John Rosen, MD
-
-
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.
Eligibility Criteria
Ages Eligible for Study
12 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Overall Study
Receive domperidone 4 times a day, weight-dependent dose
|
Domperidone taken 4 times a day, dose based on body weight
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in disease severity
Time Frame: Up to 1 year
|
refractory gastroparesis or GERD(Gastroesophageal Reflux Disease)
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jose Cocjin, MD, 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 Major Dates
Study Start
April 1, 2013
Primary Completion (Estimated)
December 1, 2035
Study Completion (Estimated)
December 1, 2035
Study Registration Dates
First Submitted
December 28, 2020
First Submitted That Met QC Criteria
January 5, 2021
First Posted (Actual)
January 7, 2021
Study Record Updates
Last Update Posted (Actual)
July 17, 2023
Last Update Submitted That Met QC Criteria
July 14, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neurologic Manifestations
- Gastrointestinal Diseases
- Stomach Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Paralysis
- Gastroesophageal Reflux
- Gastroparesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dopamine Agents
- Dopamine Antagonists
- Domperidone
Other Study ID Numbers
- 12060310
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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