The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    40
  • sponsor
    Yale University
Updated on 25 January 2021
constipation
nausea
gastrointestinal symptoms
dyspepsia
heartburn
gastroesophageal reflux
reflux
domperidone
vomiting
esophagitis

Summary

To prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy.

Description

The primary objective of this study is to prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy

Details
Condition Gastroparesis, Gastroparesis, Diabetic Gastroparesis, Gastropathy, Stomach Discomfort, Stomach Discomfort, Diabetic Gastroparesis, delayed gastric emptying, gastric atony
Treatment Domperidone
Clinical Study IdentifierNCT03810287
SponsorYale University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males or females who are 18 years of age or older
Symptoms or manifestations secondary to Gastro esophageal reflux disease (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

Exclusion Criteria

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