Treatment Use of Domperidone for Gastroparesis

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Treatment Use of Domperidone for Gastroparesis

Clinical Trial Details — Status: Temporarily not available

Administrative data

• NCT number: NCT02227927
• Other study ID #: CCF-Domperidone
• Secondary ID: CCF-Domperidone
• Status: Temporarily not available

Study information

• Verified date: May 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation. This is a long-term treatment program for prescription of this drug to all patients who, in the investigators' judgement, could benefit from its use.

Description:

The Treatment Use of Domperidone program is also available at the Cleveland Clinic Florida/Weston Gastroenterology Department. This is not a "traditional" research study, but an expanded use protocol for patients who may benefit from the drug. Because of this, this study is enrolling patients via invitation only, and as such, all expenses associated with the drug, initiation and follow up of treatment are the responsibility of the patient or the patient's third party payer.

Recruitment information / eligibility

• Status: Temporarily not available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female
• Age 18 and 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 are refractory to standard therapy.
• Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
• Patient has signed informed consent for the administration of domperidone that informs

the patient of potential adverse events including:

• increased prolactin levels
• extrapyramidal side effects
• breast changes
• cardiac arrhythmias including QT prolongation and death
• There is a potential for increased risk of adverse events with the drugs listed in the domperidone protocol addendum.

Exclusion Criteria:

• 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.
• 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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Gastroparesis
• GERD

Intervention

Drug:
• Domperidone
10-30mg oral dose, four times daily.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Scott Gabbard, MD

Country where clinical trial is conducted

United States,