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Use 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
Palo Alto Medical Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Gastroparesis focused on measuring Gastroparesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female
  2. Age 18 and older
  3. 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.
  4. 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.
  5. 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

    First Posted
    April 6, 2017
    Last Updated
    October 25, 2022
    Sponsor
    Palo Alto Medical Foundation
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    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

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