Compassionate Use of Domperidone for Refractory Gastroparesis

Gastroesophageal Reflux Clinical Trial

Official title: Compassionate Use of Domperidone for Refractory Gastroparesis

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroparesis
• GERD

• NCT number: NCT04699591
• Study type: Interventional
• Source: Children's Mercy Hospital Kansas City
• Contact: Corey Schurman, MA, CCRC
• Phone: 816-302-3076
• Email: crschurman@cmh.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 2013
• Completion date: December 2035