Domperidone for Refractory Gastrointestinal Disorders

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Gastroparesis

Clinical Trial Details

NCT number	NCT00777439
Study type	Interventional
Source	Arnold, George, M.D.
Contact	Kelly A Kolesar, BSN
Phone	412-864-7087
Email	kolesarka2@upmc.edu
Status	Recruiting
Phase	N/A
Start date	October 2008
Completion date	January 2018

View Details

See also
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