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

Yale University

Status and phase: Early Phase 1

Conditions: Gastroparesis

Treatments: Drug: Domperidone

Study type: Expanded Access

Funder types: Other

Identifiers

NCT03810287

1410014717

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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