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Treatment 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02227927
Expanded Access Status : Available
First Posted : August 28, 2014
Last Update Posted : September 4, 2020
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:

Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation.

This is a long-term treatment program for prescription of this drug to all patients who, in the investigators' judgement, could benefit from its use.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease GERD Gastroparesis Drug: Domperidone

Detailed Description:
The Treatment Use of Domperidone program is also available at the Cleveland Clinic Florida/Weston Gastroenterology Department. This is not a "traditional" research study, but an expanded use protocol for patients who may benefit from the drug. Because of this, this study is enrolling patients via invitation only, and as such, all expenses associated with the drug, initiation and follow up of treatment are the responsibility of the patient or the patient's third party payer.

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Study Type : Expanded Access
Official Title: Treatment Use of Domperidone for Gastroparesis

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
Drug Information available for: Domperidone

Intervention Details:
  • Drug: Domperidone
    10-30mg oral dose, four times daily.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Male or female
  • Age 18 and 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.
  • Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
  • Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

    • increased prolactin levels
    • extrapyramidal side effects
    • breast changes
    • cardiac arrhythmias including QT prolongation and death
    • There is a potential for increased risk of adverse events with the drugs listed in the domperidone protocol addendum.

Exclusion Criteria:

  • History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients 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): NCT02227927

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Contact: Caroline Matyas 216-445-3455

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United States, Florida
Cleveland Clinic Florida Available
Weston, Florida, United States, 33331
Contact: Alison Schneider, MD    954-659-5646   
United States, Ohio
Cleveland Clinic Available
Cleveland, Ohio, United States, 44195
Contact: Scott Gabbard, MD    216-444-6523   
Sponsors and Collaborators
The Cleveland Clinic
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Responsible Party: The Cleveland Clinic Identifier: NCT02227927    
Other Study ID Numbers: CCF-Domperidone
CCF-Domperidone ( Other Identifier: Cleveland Clinic )
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Keywords provided by The Cleveland Clinic:
Gastroesophageal Reflux Disease
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System 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