The Use of Domperidone for Gastroparesis

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Allegiance Health
ClinicalTrials.gov Identifier:
NCT01378884
First received: February 3, 2010
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Gastroparesis
Drug: Domperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monitoring Study for the Use of Gastroparesis for Patient Who Have Failed Standard Therapy

Resource links provided by NLM:


Further study details as provided by Allegiance Health:

Primary Outcome Measures:
  • Improved Gastric motility [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Patients will have improved gastric motility within three months of begining domperidone therpy


Enrollment: 0
Study Start Date: March 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Domeperidone
Patients to receive Domperidone for treatment of Gastroparesis
Drug: Domperidone
Patient to receive treatment with Domperidone
Other Name: Domperidone / Motilium

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378884

Sponsors and Collaborators
Allegiance Health
Investigators
Principal Investigator: Ivan Cubas, MD Allegiance Health Gastroenterology
  More Information

No publications provided

Responsible Party: Ivan Cubas, MD, Allegiance Health Gastroenterology
ClinicalTrials.gov Identifier: NCT01378884     History of Changes
Other Study ID Numbers: AH 10-001
Study First Received: February 3, 2010
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Allegiance Health:
Gastroparesis
Domperidone
Motilium

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014