<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03810287</url>
  </required_header>
  <id_info>
    <org_study_id>1410014717</org_study_id>
    <nct_id>NCT03810287</nct_id>
  </id_info>
  <brief_title>The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms</brief_title>
  <official_title>The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <brief_summary>
    <textblock>
      To prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered&#xD;
      adverse effects from standard medical therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to prescribe oral domperidone for patients with upper&#xD;
      GI symptoms who have failed or suffered adverse effects from standard medical therapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Temporarily not available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_intermediate>Yes</expanded_access_type_intermediate>
  </expanded_access_info>
  <condition>Gastroparesis</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Domperidone</intervention_name>
    <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.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females who are 18 years of age or older&#xD;
&#xD;
          2. Symptoms or manifestations secondary to Gastro esophageal reflux disease (GERD) (e.g.,&#xD;
             persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory&#xD;
             symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe&#xD;
             dyspepsia or severe chronic constipation that are refractory to standard therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. i. History of, or current, arrhythmias including ventricular tachycardia, ventricular&#xD;
             fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are&#xD;
             not necessarily excluded.&#xD;
&#xD;
             ii. Clinically significant bradycardia, sinus node dysfunction, or heart block.&#xD;
&#xD;
             iii. Prolonged QTc (QTc&gt;450 milliseconds for males, QTc&gt;470 milliseconds for females)&#xD;
&#xD;
             iv. Clinically significant electrolyte disorders.&#xD;
&#xD;
          2. Gastrointestinal hemorrhage or obstruction.&#xD;
&#xD;
          3. Presence of a prolactinoma (prolactin-releasing pituitary tumor).&#xD;
&#xD;
          4. Pregnant or breast feedings female.&#xD;
&#xD;
          5. Known allergy to domperidone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jill Deutsch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Digestive Diseases</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 31, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Jill Deutsch</investigator_full_name>
    <investigator_title>Assistant Professor; Director, Yale Functional Gastrointestinal Disorders Program</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Domperidone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03810287
org study id: 1410014717
nct id: NCT03810287
lead sponsor: 
To prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered
      adverse effects from standard medical therapy.
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
expanded access type intermediate: Yes
intervention type: Drug
intervention name: Domperidone
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.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jill Deutsch, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Jill Deutsch
investigator title: Assistant Professor; Director, Yale Functional Gastrointestinal Disorders Program
mesh term: Gastroparesis
mesh term: Domperidone