The Use of Domperidone for Gastroparesis

Monitoring Study for the Use of Gastroparesis for Patient Who Have Failed Standard Therapy

The purpose of this study is to determine whether domperidone can be used safely and effectively for patient with gastroparesis.

Study Overview

• Status: Withdrawn
• Conditions: Gastroparesis
• Intervention / Treatment: Drug: Domperidone

Detailed Description

Individuals who have been diagnosed with gastroparesis and have failed at least one standard therapy will be offered to trial domperidone as a possible remedy to their condition. Patients on the medication will be expected to to be followed by the physician at 3 months, 6 months 12months, and then annually while on the medication. Any change or significant adverse reaction to the medication or in their condition should be reported immediately to their physician.

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female
2. Age 18 or 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. Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.

5. Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:

   • increased prolactin levels,
   • extrapyramidal side effects,
   • breast changes,
   • cardiac arrhythmias including QT prolongation, and

Exclusion Criteria:

1. History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
2. History of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
3. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
4. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
5. Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo-obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
6. Pregnant or breast feeding female.
7. Known allergy to domperidone or any components of the domperidone formulation.
8. Significantly significant electrolyte disorders.
9. Gastrointestinal hemorrhage or obstruction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Domeperidone; Patients to receive Domperidone for treatment of Gastroparesis	Drug: Domperidone; Patient to receive treatment with Domperidone; Other Names: Domperidone / Motilium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved Gastric motility	Patients will have improved gastric motility within three months of begining domperidone therpy	3 months

Collaborators and Investigators

• Sponsor: Allegiance Health
• Investigators: Principal Investigator: Ivan Cubas, MD, Allegiance Health Gastroenterology

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: February 3, 2010
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 23, 2011

Study Record Updates

• Last Update Posted (Estimate): March 19, 2013
• Last Update Submitted That Met QC Criteria: March 18, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Domperidone; Gastroparesis; Motilium
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine Antagonists; Domperidone
• Other Study ID Numbers: AH 10-001