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The Use of Domperidone for Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01378884
Recruitment Status : Withdrawn
First Posted : June 23, 2011
Last Update Posted : March 19, 2013
Information provided by:
Allegiance Health

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

Condition or disease Intervention/treatment Phase
Gastroparesis Drug: Domperidone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monitoring Study for the Use of Gastroparesis for Patient Who Have Failed Standard Therapy
Study Start Date : March 2010
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Domperidone

Arm Intervention/treatment
Experimental: Domeperidone
Patients to receive Domperidone for treatment of Gastroparesis
Drug: Domperidone
Patient to receive treatment with Domperidone
Other Name: Domperidone / Motilium

Primary Outcome Measures :
  1. Improved Gastric motility [ Time Frame: 3 months ]
    Patients will have improved gastric motility within three months of begining domperidone therpy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01378884

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

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Responsible Party: Ivan Cubas, MD, Allegiance Health Gastroenterology Identifier: NCT01378884     History of Changes
Other Study ID Numbers: AH 10-001
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013

Keywords provided by Allegiance Health:

Additional relevant MeSH terms:
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Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action