Back to resultsThe Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms
Primary Purpose
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 Gastroparesis
Eligibility Criteria
Inclusion Criteria:
- Males or females who are 18 years of age or older
- Symptoms or manifestations secondary to Gastro esophageal reflux disease (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.
Exclusion Criteria:
i. 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.
ii. Clinically significant bradycardia, sinus node dysfunction, or heart block.
iii. Prolonged QTc (QTc>450 milliseconds for males, QTc>470 milliseconds for females)
iv. Clinically significant electrolyte disorders.
- Gastrointestinal hemorrhage or obstruction.
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- Pregnant or breast feedings female.
- Known allergy to domperidone
Sites / Locations
- Yale Digestive Diseases
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03810287
Brief Title
The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms
Official Title
The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms
Study Type
Expanded Access
2. Study Status
Record Verification Date
January 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
Principal Investigator
Name of the Sponsor
Yale University
4. Oversight
5. Study Description
Brief Summary
To prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy.
Detailed Description
The primary objective of this study is to prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Domperidone
Intervention Description
Domperidone will be prescribed for patients with upper GI symptoms at an initial dose of 10 mg up to 4 times a day (prior to each meal and at bedtime). It is possible that the dose of domperidone may be increased to 20 mg if symptoms are not adequately controlled on the initial dose.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females who are 18 years of age or older
Symptoms or manifestations secondary to Gastro esophageal reflux disease (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.
Exclusion Criteria:
i. 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.
ii. Clinically significant bradycardia, sinus node dysfunction, or heart block.
iii. Prolonged QTc (QTc>450 milliseconds for males, QTc>470 milliseconds for females)
iv. Clinically significant electrolyte disorders.
Gastrointestinal hemorrhage or obstruction.
Presence of a prolactinoma (prolactin-releasing pituitary tumor).
Pregnant or breast feedings female.
Known allergy to domperidone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Deutsch, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Digestive Diseases
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms
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