Domperidone for Refractory Gastrointestinal Disorders

  • STATUS
    Not Recruiting
  • participants needed
    75
  • sponsor
    Arnold, George, M.D.
Updated on 21 January 2021
constipation
nausea
dyspepsia
heartburn
gastroesophageal reflux
domperidone
respiratory symptoms
vomiting
prolactin
esophagitis
gastrointestinal disorders
cardiac arrhythmias

Summary

The purpose of this study is to prescribe oral domperidone for subjects with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.

Description

Domperidone is a dopamine-2 receptor antagonist. It acts as a prokinetic agent through its effects on the chemoreceptor trigger zone and the motor function of the stomach and small intestines. It does not cause any adverse neurological symptoms and has an excellent safety profile for long-term oral administration in recommended doses.

In the United States, domperidone is not approved by the Food and Drug Administration (FDA) and cannot be obtained by routine prescriptions or covered by health care insurance plans. It is also illegal to write a prescription for the subject to obtain the drug outside the U.S. Domperidone can be administered legally by obtaining a FDA Investigational New Drug (IND) application with Institutional Review Board (IRB) approval.

This study will follow FDA and IRB regulations and provide domperidone to subjects with gastrointestinal disorders who have failed from standard therapy.

Details
Condition Gastroparesis
Treatment Domperidone, Domperidone
Clinical Study IdentifierNCT00777439
SponsorArnold, George, M.D.
Last Modified on21 January 2021

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