Back to resultsTreatment Use of Domperidone for Gastroparesis
Primary Purpose
Gastroesophageal Reflux Disease, GERD, Gastroparesis
Status
Temporarily not available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Domperidone
Sponsored by
About this trial
This is an expanded access trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal Reflux Disease, GERD, Gastroparesis, Domperidone
Eligibility 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
Sites / Locations
- Cleveland Clinic Florida
- Cleveland Clinic
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02227927
Brief Title
Treatment Use of Domperidone for Gastroparesis
Official Title
Treatment Use of Domperidone for Gastroparesis
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Temporarily not available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Scott Gabbard, MD
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, GERD, Gastroparesis
Keywords
Gastroesophageal Reflux Disease, GERD, Gastroparesis, Domperidone
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Domperidone
Intervention Description
10-30mg oral dose, four times daily.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment Use of Domperidone for Gastroparesis
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