Domperidone Expanded Access Treatment Program

Gastroparesis Clinical Trial

Official title:

Domperidone Protocol - FDA Expanded Access Program

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT04996134
• Other study ID #: 17-123 (16-817)
• Status: Available

Study information

• Verified date: February 2024
• Source: Aurora Health Care
• Contact: Devin Spaulding, BS
• Phone: 920-288-3127
• Email: devin.spaulding[@]aah.org
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

To allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy.

Description:

To provide oral domperidone to patients ≥12 years of age where, according to the investigator's judgment, a prokinetic effect is needed for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation in patients whom the potential benefit may outweigh the risk of cardiovascular adverse reactions including QT prolongation, Torsades de Pointes, and death.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Male or female

2. Age 12 and older

3. 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.

4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.

5. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events

Exclusion Criteria:

History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.

1. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc>470 milliseconds for females).

2. Hepatic dysfunction

3. Renal insufficiency

4. Clinically significant electrolyte disorders.

5. Gastrointestinal hemorrhage or obstruction

6. Presence of a prolactinoma (prolactin-releasing pituitary tumor).

7. Pregnant or breast feeding female

8. Known allergy to domperidone

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• Domperidone Oral Product
10-30 mg of oral domperidone administered QID.

Locations

Country	Name	City	State
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States,