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Domperidone Expanded Access Treatment Program

Primary Purpose

Gastroparesis

Status

Available

Phase

Locations

United States

Study Type

Expanded Access

Intervention

Domperidone Oral Product

About this trial

This is an expanded access trial for Gastroparesis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

Male or female
Age 12 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

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.

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

Sites / Locations

Aurora BayCare Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT04996134

First Posted

August 3, 2021

Last Updated

January 24, 2023

Sponsor

Aurora Health Care

1. Study Identification

Unique Protocol Identification Number

NCT04996134

Brief Title

Domperidone Expanded Access Treatment Program

Official Title

Domperidone Protocol - FDA Expanded Access Program

Study Type

Expanded Access

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aurora Health Care

4. Oversight

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroparesis

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Domperidone Oral Product

Intervention Description

10-30 mg of oral domperidone administered QID.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Eligibility Criteria

Inclusion Criteria: Male or female Age 12 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 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. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc>470 milliseconds for females). Hepatic dysfunction Renal insufficiency 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Taylor Romdenne, BS, CCRP

Phone

920-288-3127

Taylor.Romdenne@aah.org

Facility Information:

Facility Name

Aurora BayCare Medical Center

City

Green Bay

State/Province

Wisconsin

ZIP/Postal Code

54311

Country

United States

Individual Site Status

Available

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Taylor Romdenne, BS, CCRP

Phone

920-288-3127

Taylor.Romdenne@aah.org

First Name & Middle Initial & Last Name & Degree

John J Bosco, MD

12. IPD Sharing Statement

Learn more about this trial

Domperidone Expanded Access Treatment Program

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