Gastroparesis Clinical Trial
Official title:
An Investigational New Drug Program for the Use of Domperidone in the Treatment of Refractory Gastroesophageal Reflux Disease and Other Gastrointestinal Motility Disorders
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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