<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/NCT02227927</url>
  </required_header>
  <id_info>
    <org_study_id>CCF-Domperidone</org_study_id>
    <secondary_id>CCF-Domperidone</secondary_id>
    <nct_id>NCT02227927</nct_id>
  </id_info>
  <brief_title>Treatment Use of Domperidone for Gastroparesis</brief_title>
  <official_title>Treatment Use of Domperidone for Gastroparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scott Gabbard, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <brief_summary>
    <textblock>
      Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux&#xD;
      disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation.&#xD;
&#xD;
      This is a long-term treatment program for prescription of this drug to all patients who, in&#xD;
      the investigators' judgement, could benefit from its use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Treatment Use of Domperidone program is also available at the Cleveland Clinic&#xD;
      Florida/Weston Gastroenterology Department. This is not a &quot;traditional&quot; research study, but&#xD;
      an expanded use protocol for patients who may benefit from the drug. Because of this, this&#xD;
      study is enrolling patients via invitation only, and as such, all expenses associated with&#xD;
      the drug, initiation and follow up of treatment are the responsibility of the patient or the&#xD;
      patient's third party payer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Temporarily not available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <condition>Gastroesophageal Reflux Disease</condition>
  <condition>GERD</condition>
  <condition>Gastroparesis</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Domperidone</intervention_name>
    <description>10-30mg oral dose, four times daily.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Age 18 and older&#xD;
&#xD;
          -  Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn,&#xD;
             upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility&#xD;
             disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation&#xD;
             that are refractory to standard therapy.&#xD;
&#xD;
          -  Patients must have a comprehensive evaluation to eliminate other causes of their&#xD;
             symptoms.&#xD;
&#xD;
          -  Patient has signed informed consent for the administration of domperidone that informs&#xD;
             the patient of potential adverse events including:&#xD;
&#xD;
               -  increased prolactin levels&#xD;
&#xD;
               -  extrapyramidal side effects&#xD;
&#xD;
               -  breast changes&#xD;
&#xD;
               -  cardiac arrhythmias including QT prolongation and death&#xD;
&#xD;
               -  There is a potential for increased risk of adverse events with the drugs listed&#xD;
                  in the domperidone protocol addendum.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  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;
          -  Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged&#xD;
             QTc (QTc&gt; 450 milliseconds for males, QTc&gt;470 milliseconds for females).&#xD;
&#xD;
          -  Clinically significant electrolyte disorders.&#xD;
&#xD;
          -  Gastrointestinal hemorrhage or obstruction&#xD;
&#xD;
          -  Presence of a prolactinoma (prolactin-releasing pituitary tumor).&#xD;
&#xD;
          -  Pregnant or breast feeding female&#xD;
&#xD;
          -  Known allergy to domperidone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Cleveland Clinic Florida</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>May 17, 2023</last_update_submitted>
  <last_update_submitted_qc>May 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Scott Gabbard, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Gastroesophageal Reflux Disease</keyword>
  <keyword>GERD</keyword>
  <keyword>Gastroparesis</keyword>
  <keyword>Domperidone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <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/NCT02227927
org study id: CCF-Domperidone
secondary id: CCF-Domperidone
nct id: NCT02227927
lead sponsor: 
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.
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.
intervention type: Drug
intervention name: Domperidone
description: 10-30mg oral dose, four times daily.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Scott Gabbard, MD
investigator title: Principal Investigator
mesh term: Gastroesophageal Reflux
mesh term: Gastroparesis
mesh term: Domperidone