The Use of Domperidone for Gastroparesis

NCT ID: NCT01378884

Last Updated: 2013-03-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-03-31

Brief Summary

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

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.

Conditions

Gastroparesis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Domeperidone

Patients to receive Domperidone for treatment of Gastroparesis

Group Type: EXPERIMENTAL

Domperidone

Intervention Type: DRUG

Patient to receive treatment with Domperidone

Interventions

Domperidone

Patient to receive treatment with Domperidone

Intervention Type: DRUG

Other Intervention Names

Domperidone / Motilium

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allegiance Health

OTHER

Sponsor Role: lead

Responsible Party

Allegiance Health Gastroenterology

Principal Investigators

Ivan Cubas, MD

Role: PRINCIPAL_INVESTIGATOR

Allegiance Health Gastroenterology

Other Identifiers

AH 10-001

Identifier Type: -

Identifier Source: org_study_id