Back to results

Compassionate Use of Domperidone for Refractory Gastroparesis

Primary Purpose

GERD, Gastroesophageal Reflux, Gastroparesis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Domperidone

About this trial

This is an interventional treatment trial for GERD focused on measuring reflux, acid reflux

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female
Age 12 - 21
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
- There is a potential for increased risk of adverse events with the drugs and herbal supplements listed in the addendum (See Addendum on pages 24 and 25)
- The coordinator/investigator will have a discussion with the family about the use of any of the medications and herbal supplements listed in the addendum to make sure they understand the increased risk of their use and the need to contact the investigators prior to using any of the listed medications and herbal supplements.

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 Tc (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

Sites / Locations

Children's Mercy Hospitals and ClinicsRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Overall Study

Arm Description

Receive domperidone 4 times a day, weight-dependent dose

Outcomes

Primary Outcome Measures

Change in disease severity

refractory gastroparesis or GERD(Gastroesophageal Reflux Disease)

Secondary Outcome Measures

Full Information

NCT ID

NCT04699591

First Posted

December 28, 2020

Last Updated

July 14, 2023

Sponsor

Children's Mercy Hospital Kansas City

1. Study Identification

Unique Protocol Identification Number

NCT04699591

Brief Title

Compassionate Use of Domperidone for Refractory Gastroparesis

Official Title

Compassionate Use of Domperidone for Refractory Gastroparesis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 2013 (undefined)

Primary Completion Date

December 2035 (Anticipated)

Study Completion Date

December 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Children's Mercy Hospital Kansas City

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this program is to allow the use of domperidone in children from 12 to 21 years of age with symptoms related to motility disorders and Gastroesophageal reflux disease (GERD) who have failed all the standard treatments for their condition.

Detailed Description

The following will need to be completed before the investigational treatment can begin: Your medical history will be reviewed to make sure domperidone is a safe option for treatment You will have a physical examination, including heart and breathing rates, blood pressure, height, weight, and an ECG. An ECG measures the electrical activity of the heart over a period of time. This is a non-invasive procedure and involves attaching sticky pads to your chest and recording your body's electrical activity on a machine. The study doctor/nurse will explain this in more detail to you. You will have up to 3 teaspoons of blood drawn through a needle in the arm to make sure it is safe for you to receive domperidone. You will have a pregnancy test if you are female. If your tests results are acceptable, the following will happen to you: You will take domperidone 4 times per day. The dose will be calculated by your doctor according to your weight. Every two months for the first year, you will have a physical examination, including heart and breathing rates, blood pressure, height, weight, up to 3 teaspoons of blood drawn through a needle in your arm to measure blood levels, and an ECG. You will also have an ECG anytime there is an increase in the amount of domperidone you are taking. After the first year, if you are benefitting from taking domperidone you will have a physical examination, blood draw and ECG every six months until you stop taking domperidone.

6. Conditions and Keywords

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

GERD, Gastroesophageal Reflux, Gastroparesis

Keywords

reflux, acid reflux

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Overall Study

Arm Type

Other

Arm Description

Receive domperidone 4 times a day, weight-dependent dose

Intervention Type

Drug

Intervention Name(s)

Domperidone

Other Intervention Name(s)

Motilium, Motillium, Motinorm Costi, Nomit, Brulium, Molax

Intervention Description

Domperidone taken 4 times a day, dose based on body weight

Primary Outcome Measure Information:

Title

Change in disease severity

Description

refractory gastroparesis or GERD(Gastroesophageal Reflux Disease)

Time Frame

Up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female Age 12 - 21 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 There is a potential for increased risk of adverse events with the drugs and herbal supplements listed in the addendum (See Addendum on pages 24 and 25) The coordinator/investigator will have a discussion with the family about the use of any of the medications and herbal supplements listed in the addendum to make sure they understand the increased risk of their use and the need to contact the investigators prior to using any of the listed medications and herbal supplements. 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 Tc (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

Central Contact Person:

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

Corey Schurman, MA, CCRC

Phone

816-302-3076

crschurman@cmh.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose Cocjin, MD

Organizational Affiliation

Children's Mercy Hospital Kansas City

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Mercy Hospitals and Clinics

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Corey Schurman, MA

Phone

816-802-1167

crschurman@cmh.edu

First Name & Middle Initial & Last Name & Degree

Jose Cocjin, MD

Phone

816-302-3400

jcocjin@cmh.edu

First Name & Middle Initial & Last Name & Degree

Jose Cocjin, MD

First Name & Middle Initial & Last Name & Degree

John Rosen, MD

12. IPD Sharing Statement

Learn more about this trial

Compassionate Use of Domperidone for Refractory Gastroparesis

We'll reach out to this number within 24 hrs