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

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Temporarily not available

Administrative data

• NCT number: NCT03810287
• Other study ID #: 1410014717
• Status: Temporarily not available

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Temporarily not available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Yale Digestive Diseases	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Jill Deutsch

Country where clinical trial is conducted

United States,