Compassionate Use of Domperidone for Refractory Gastroparesis

  • STATUS
    Recruiting
  • End date
    Dec 9, 2035
  • participants needed
    20
  • sponsor
    Children's Mercy Hospital Kansas City
Updated on 9 June 2022
constipation
nausea
dyspepsia
heartburn
gastroesophageal reflux
reflux
domperidone
vomiting
prolactin
esophagitis
cardiac arrhythmias

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.

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.

Details
Condition GERD, Gastroesophageal Reflux, Gastroparesis
Treatment Domperidone
Clinical Study IdentifierNCT04699591
SponsorChildren's Mercy Hospital Kansas City
Last Modified on9 June 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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