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Domperidone for Relief of 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. Identifier: NCT00761254
Recruitment Status : Terminated (PI withdrew due to increased responsibilities in clinical department.)
First Posted : September 29, 2008
Last Update Posted : September 13, 2012
Information provided by (Responsible Party):
Carle Physician Group

Brief Summary:
The purpose of this study is to make Domperidone available to patients with gastrointestinal disorders who have failed standard therapy and who might benefit from it.

Condition or disease Intervention/treatment Phase
Gastroparesis GERD Esophagitis Dyspepsia Chronic Idiopathic Constipation Nausea Vomiting Drug: Domperidone Not Applicable

Detailed Description:

Domperidone is the only medication that is a true prokinetic with a low percentage of side effects that is useful in the treatment of certain GI conditions, including gastroparesis and other motility disorders.

According to recent regulations, writing prescriptions for subject to obtain domperidone outside the United States has been determined to be illegal and the FDA has issued warnings against pharmacies compounding domperidone. The legal way of administering domperidone is by obtaining an Investigational New Drug Application.

This study is an effort to both follow federal regulations and provide the medication to subjects who would benefit from it where standard therapy has failed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy
Study Start Date : August 2008
Estimated Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Domperidone

Intervention Details:
  • Drug: Domperidone
    Initially, 10mg of oral Domperidone will be administered 2-4 times a day as needed. This dosage may be increased or decreased depending on how the subject responds to the drug.
    Other Name: Motilium

Primary Outcome Measures :
  1. Relief for patients with gastrointestinal disorders who have failed standard therapy [ Time Frame: As long as the subjects continue to take Domperidone. ]

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:

  • 18 years 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 is refractory to standard therapy
  • subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.

Exclusion Criteria:

  • history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, and Torsade de pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
  • clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females.)
  • clinically significant electrolyte disorders.
  • gastrointestinal hemorrhage or obstruction.
  • presence of a prolactinoma (prolactin-releasing pituitary tumor.)
  • pregnant or breast feeding female.
  • known allergy to Domperidone.

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): NCT00761254

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United States, Illinois
Carle Health Care Incorporated d/b/a Carle Physician Group
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
Carle Physician Group
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Principal Investigator: Andrew Batey, M.D. Carle Health Care Incorporated d/b/a Carle Physician Group
Study Director: Anna Keck, PhD Carle Foundation Hospital
Study Director: James Dougherty, MD Carle Foundation Hospital
Principal Investigator: Eugene Greenberg, MD Carle Physician Group
Principal Investigator: Vicki Shah, PA Carle Physician Group
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Responsible Party: Carle Physician Group Identifier: NCT00761254    
Other Study ID Numbers: 08-153
First Posted: September 29, 2008    Key Record Dates
Last Update Posted: September 13, 2012
Last Verified: September 2012
Keywords provided by Carle Physician Group:
Additional relevant MeSH terms:
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Digestive System Diseases
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Esophageal Diseases
Stomach Diseases
Neurologic Manifestations
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action