The Use of Domperidone for Gastroparesis

NCT01378884 | Withdrawn Phase 3 DMC

• 1 other identifier: AH 10-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gastroparesis

Keywords

Gastroparesis; Domperidone; Motilium

Outcome Measures

Primary Outcomes (1)

• Improved Gastric motility

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

  3 months

Study Arms (1)

Domeperidone

EXPERIMENTAL

Patients to receive Domperidone for treatment of Gastroparesis

Drug: Domperidone

Interventions

Domperidone DRUG

Patient to receive treatment with Domperidone

Also known as: Domperidone / Motilium

Domeperidone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allegiance Health: lead

MeSH Terms

Conditions

Gastroparesis

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ivan Cubas, MD

  Allegiance Health Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: June 23, 2011
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2014
• Last Updated: March 19, 2013

Record last verified: 2013-03