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

NCT03810287 | Unknown

• 1 other identifier: 1410014717
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroparesis

Interventions

Domperidone DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females who are 18 years of age or older
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Digestive Diseases

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jill Deutsch, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: January 18, 2019
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

US (1)