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Treatment Use of Domperidone for Gastroparesis

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ClinicalTrials.gov Identifier: NCT02227927
Expanded Access Status : Available
First Posted : August 28, 2014
Last Update Posted : November 21, 2017
Sponsor:
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. As such, all expenses associated with the drug, initiation and follow up of treatment are the responsiblity of the patient or the patient's third party payor.

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02227927


Contacts
Contact: Jeannie Bongorno 216-445-0516 bongorj@ccf.org

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact: Scott Gabbard, MD    216-444-6523    GABBARS@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02227927     History of Changes
Other Study ID Numbers: CCF-Domperidone
CCF-Domperidone ( Other Identifier: Cleveland Clinic )
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Keywords provided by The Cleveland Clinic:
Gastroesophageal Reflux Disease
GERD
Gastroparesis
Domperidone

Additional relevant MeSH terms:
Gastroparesis
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action