The Use of Domperidone for Gastroparesis

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01378884
• Other study ID #: AH 10-001
• Status: Withdrawn
• Phase: Phase 3
• First received: February 3, 2010
• Last updated: March 18, 2013
• Start date: March 2010
• Est. completion date: March 2014

Study information

• Verified date: March 2013
• Source: Allegiance Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• Domperidone
Patient to receive treatment with Domperidone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allegiance Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved Gastric motility	Patients will have improved gastric motility within three months of begining domperidone therpy	3 months	Yes