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Domperidone for Refractory Gastrointestinal Disorders

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.
ClinicalTrials.gov Identifier: NCT00777439
Recruitment Status : Unknown
Verified August 2016 by George Arnold, MD, Arnold, George, M.D..
Recruitment status was:  Recruiting
First Posted : October 22, 2008
Last Update Posted : August 18, 2016
Information provided by (Responsible Party):
George Arnold, MD, Arnold, George, M.D.

Brief Summary:
The purpose of this study is to prescribe oral domperidone for subjects with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.

Condition or disease Intervention/treatment Phase
Gastroparesis Drug: Domperidone Not Applicable

Detailed Description:

Domperidone is a dopamine-2 receptor antagonist. It acts as a prokinetic agent through its effects on the chemoreceptor trigger zone and the motor function of the stomach and small intestines. It does not cause any adverse neurological symptoms and has an excellent safety profile for long-term oral administration in recommended doses.

In the United States, domperidone is not approved by the Food and Drug Administration (FDA) and cannot be obtained by routine prescriptions or covered by health care insurance plans. It is also illegal to write a prescription for the subject to obtain the drug outside the U.S. Domperidone can be administered legally by obtaining a FDA Investigational New Drug (IND) application with Institutional Review Board (IRB) approval.

This study will follow FDA and IRB regulations and provide domperidone to subjects with gastrointestinal disorders who have failed from standard therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigational New Drug Program for the Use of Domperidone in the Treatment of Refractory Gastroesophageal Reflux Disease and Other Gastrointestinal Motility Disorders
Study Start Date : October 2008
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Domperidone

Arm Intervention/treatment
All eligible subjects will receive domperidone in an open label, single group assignment.
Drug: Domperidone
10 mg of oral domperidone will be administered 4 times daily. This dose may be increased to 20 mg 4 times daily or 30 mg 4 times daily, depending on how the subject responds to the drug.
Other Name: Domperidone maleate, Motilium

Primary Outcome Measures :
  1. Improvement of symptoms for patients with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment. [ Time Frame: Domperidone will be prescrided as long as patients benefit from taking it. ]

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:

  • 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
    • there is a potential for increased risk of adverse events with the drugs listed in the addendum

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.

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 ClinicalTrials.gov identifier (NCT number): NCT00777439

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Contact: Kelly A Kolesar, BSN 412-864-7087 kolesarka2@upmc.edu
Contact: George L. Arnold, MD 412-864-7087 arnoldgl@upmc.edu

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United States, Pennsylvania
Division of Gastroenterology, Hepatology and Nutrition, UPMC Presbyterian Digesive Disorders Center, 3rd Floor, 200 Lothrop Street Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kelly A. Kolesar, BSN    412-864-7087    kolesarka2@upmc.edu   
Principal Investigator: George L. Arnold, MD         
Sponsors and Collaborators
Arnold, George, M.D.
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Principal Investigator: George L. Arnold, MD George L. Arnold, MD, FACP
Publications of Results:
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Responsible Party: George Arnold, MD, Principal Investigator, Arnold, George, M.D.
ClinicalTrials.gov Identifier: NCT00777439    
Other Study ID Numbers: GLA102024
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016
Keywords provided by George Arnold, MD, Arnold, George, M.D.:
Gastrointestinal Diseases
Neurologic Manifestations
Stomach Diseases
Digestive System Diseases
Esophageal Disorders
Additional relevant MeSH terms:
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Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents