Back to results

The Use of Domperidone for Gastroparesis

Primary Purpose

Gastroparesis

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Domperidone

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring Gastroparesis, Domperidone, Motilium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
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.
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.
Presence of a prolactinoma (prolactin-releasing pituitary tumor).
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.)
Pregnant or breast feeding female.
Known allergy to domperidone or any components of the domperidone formulation.
Significantly significant electrolyte disorders.
Gastrointestinal hemorrhage or obstruction.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Domeperidone

Arm Description

Patients to receive Domperidone for treatment of Gastroparesis

Outcomes

Primary Outcome Measures

Improved Gastric motility

Patients will have improved gastric motility within three months of begining domperidone therpy

Secondary Outcome Measures

Full Information

NCT ID

NCT01378884

First Posted

February 3, 2010

Last Updated

March 18, 2013

Sponsor

Allegiance Health

1. Study Identification

Unique Protocol Identification Number

NCT01378884

Brief Title

The Use of Domperidone for Gastroparesis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Withdrawn

Study Start Date

March 2010 (undefined)

Primary Completion Date

March 2012 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Allegiance Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Gastroparesis

Keywords

Gastroparesis, Domperidone, Motilium

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Domeperidone

Arm Type

Experimental

Arm Description

Patients to receive Domperidone for treatment of Gastroparesis

Intervention Type

Drug

Intervention Name(s)

Domperidone

Other Intervention Name(s)

Domperidone / Motilium

Intervention Description

Patient to receive treatment with Domperidone

Primary Outcome Measure Information:

Title

Improved Gastric motility

Description

Patients will have improved gastric motility within three months of begining domperidone therpy

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female Age 18 or 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. Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms. 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: History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure. 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. 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. Presence of a prolactinoma (prolactin-releasing pituitary tumor). 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.) Pregnant or breast feeding female. Known allergy to domperidone or any components of the domperidone formulation. Significantly significant electrolyte disorders. Gastrointestinal hemorrhage or obstruction.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ivan Cubas, MD

Organizational Affiliation

Allegiance Health Gastroenterology

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

The Use of Domperidone for Gastroparesis

We'll reach out to this number within 24 hrs