Back to resultsUse of Domperidone for Treatment of Upper Gastrointestinal Disorders (Domperidone)
Primary Purpose
Gastroparesis
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Domperidone
Sponsored by
About this trial
This is an expanded access trial for Gastroparesis focused on measuring Gastroparesis
Eligibility Criteria
Inclusion Criteria:
- Male or female
- Age 18 and older
- Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
- Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
- Increased prolactin levels
- Breast changes
- Extrapyramidal side effects
- Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)
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.
2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females).
3. Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
4. Gastrointestinal hemorrhage or obstruction. 5. Presence of a prolactinoma (prolactin-releasing pituitary tumor). 6. Pregnant or breast feedings female. 7. Known allergy to domperidone.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03128398
First Posted
April 6, 2017
Last Updated
October 25, 2022
Sponsor
Palo Alto Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03128398
Brief Title
Use of Domperidone for Treatment of Upper Gastrointestinal Disorders
Acronym
Domperidone
Official Title
Use of Domperidone for Treatment of Upper Gastrointestinal Disorders
Study Type
Expanded Access
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palo Alto Medical Foundation
4. Oversight
5. Study Description
Brief Summary
This is an Expanded Access to Investigational Drug program available through the FDA. Some specific conditions to qualify for this program includes gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients failing standard therapies for these conditions may be eligible to receive domperidone. This program facilitates availability of investigational drugs, (such as domperidone) to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the patients's disease or condition. Authorization must be obtained from FDA prior to the importation, interstate shipment and administration of domperidone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Gastroparesis
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Domperidone
Intervention Description
Availability of Domperidone to patients with serious gastrointestinal diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient's disease or condition.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female
Age 18 and older
Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
Increased prolactin levels
Breast changes
Extrapyramidal side effects
Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)
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.
2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females).
3. Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
4. Gastrointestinal hemorrhage or obstruction. 5. Presence of a prolactinoma (prolactin-releasing pituitary tumor). 6. Pregnant or breast feedings female. 7. Known allergy to domperidone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katerina Shetler, MD
Organizational Affiliation
Palo Alto Medical Foundation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Use of Domperidone for Treatment of Upper Gastrointestinal Disorders
We'll reach out to this number within 24 hrs