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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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

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Detailed Description

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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

Conditions

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Gastroparesis

Interventions

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Domperidone

Domperidone will be prescribed for patients with upper GI symptoms at an initial dose of 10 mg up to 4 times a day (prior to each meal and at bedtime). It is possible that the dose of domperidone may be increased to 20 mg if symptoms are not adequately controlled on the initial dose.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males or females who are 18 years of age or older
2. 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

1. 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.
2. Gastrointestinal hemorrhage or obstruction.
3. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
4. Pregnant or breast feedings female.
5. Known allergy to domperidone

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No