Domperidone for Relief of Gastrointestinal Disorders

Study Overview
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Brief Summary
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The purpose of this study is to make Domperidone available to patients with gastrointestinal disorders who have failed standard therapy and who might benefit from it.

Detailed Description
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Domperidone is the only medication that is a true prokinetic with a low percentage of side effects that is useful in the treatment of certain GI conditions, including gastroparesis and other motility disorders. According to recent regulations, writing prescriptions for subject to obtain domperidone outside the United States has been determined to be illegal and the FDA has issued warnings against pharmacies compounding domperidone. The legal way of administering domperidone is by obtaining an Investigational New Drug Application. This study is an effort to both follow federal regulations and provide the medication to subjects who would benefit from it where standard therapy has failed.

Official Title
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Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy

Conditions
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Gastroparesis, GERD, Esophagitis, Dyspepsia, Chronic Idiopathic Constipation, Nausea, Vomiting

Intervention / Treatment
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* Drug: Domperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older 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 is refractory to standard therapy subjects must have a comprehensive evaluation to eliminate other causes of their symptoms. Exclusion Criteria: history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, and Torsade de pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded. clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Domperidone|Initially, 10mg of oral Domperidone will be administered 2-4 times a day as needed. This dosage may be increased or decreased depending on how the subject responds to the drug.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief for patients with gastrointestinal disorders who have failed standard therapy |  | As long as the subjects continue to take Domperidone. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Domperidone, Gastroparesis