<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/NCT01711918</url>
  </required_header>
  <id_info>
    <org_study_id>Domperidone</org_study_id>
    <nct_id>NCT01711918</nct_id>
  </id_info>
  <brief_title>Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis</brief_title>
  <official_title>Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ron Schey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To provide oral domperidone to patients between the ages of 18 and 60 years of age, according&#xD;
      to the investigator's judgment, a prokinetic effect is needed for the relief of severe&#xD;
      gastroparesis. We have defined severe gastroparesis as 1) positive gastric emptying&#xD;
      scintigraphy (more than 10% residue at 4 hours), 2) nausea, 3) early satiety, 4) abdominal&#xD;
      pain. We will recruit patients for two years and the patients will be given domperidone for&#xD;
      up to two years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of Overall Symptoms Based on Likert Scale</measure>
    <time_frame>Baseline and End of study (2 years or last visit if patient withdraws)</time_frame>
    <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of Nausea Based on Likert Scale</measure>
    <time_frame>Baseline and End of study (2 years or last visit if patient withdraws)</time_frame>
    <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of Vomiting Based on Likert Scale</measure>
    <time_frame>Baseline and End of study (2 years or last visit if patient withdraws)</time_frame>
    <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of Abdominal Bloating or Distention Based on Likert Scale</measure>
    <time_frame>Baseline and End of study (2 years or last visit if patient withdraws)</time_frame>
    <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale</measure>
    <time_frame>Baseline and End of study (2 years or last visit if patient withdraws)</time_frame>
    <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Patients With Gastroparesis Who Have Failed Standard Therapy</condition>
  <arm_group>
    <arm_group_label>Domperidone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will received domperidone at a dose of 10mg given up to three times per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Domperidone</intervention_name>
    <description>oral tablet; dose is 10mg per tablet given up to 3 times daily.</description>
    <arm_group_label>Domperidone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or Female&#xD;
&#xD;
          2. Age 18 - 60&#xD;
&#xD;
          3. Symptoms or manifestation secondary to gastroparesis such as vomiting, nausea, the&#xD;
             feeling you are full after you start eating, and abdominal pain.&#xD;
&#xD;
          4. Subjects must have a comprehensive evaluation to eliminate other causes of their&#xD;
             symptoms which includes gastric emptying scintigraphy, esophagogastroduodenoscopy&#xD;
             (EGD), and the patient's subjective symptoms.&#xD;
&#xD;
          5. Subject has signed informed consent for the administration of domperidone that informs&#xD;
             the patient of potential adverse events&#xD;
&#xD;
          6. Female subjects must be:&#xD;
&#xD;
               1. surgically sterile (have had a hysterectomy or bilateral oophorectomy, or tubal&#xD;
                  ligation)&#xD;
&#xD;
               2. if sexual active, practicing an effective method of birth control such as&#xD;
                  hormonal prescription oral contraceptives, progesterone implants or injections,&#xD;
                  contraceptive patch, intrauterine device, or maintenance of a monogamous&#xD;
                  relationship with a male partner who has been surgically sterilized by vasectomy.&#xD;
                  A double barrier method such as condoms, diaphragms, or cervical caps with&#xD;
                  spermicidal foam, cream, or gel may be used as a method of birth control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of, or current, arrhythmias including ventricular tachycardia, ventricular&#xD;
             fibrillation, atrial fibrilation and Torsade des Pointes, subjects with minor forms of&#xD;
             ectopy (PACs) are not necessarily excluded&#xD;
&#xD;
          2. 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;
          3. Clinically significant electrolyte disorders&#xD;
&#xD;
          4. Gastrointestinal hemmorrhage or obstruction&#xD;
&#xD;
          5. Presence of a prolactinoma (prolactin-releasing pituitary tumor)&#xD;
&#xD;
          6. Pregnant or breast feeding female&#xD;
&#xD;
          7. Known allergy to domperidone The following medications are prohibited during the&#xD;
             study: antidepressants: doxepin, clomipramine, amopxapine, trazodone, venlafaxine,&#xD;
             nefazodone, fluvoxamine, paroxetine, fluoxetine, sertraline, amitriptyline,&#xD;
             maprotiline, desipramine, nortriptyline, trimipramine, imipramine, protriptyline;&#xD;
             anti-psychotics: haloperidol, chlorpromazine, chlorpromazine pimozide, sertindole,&#xD;
             quetiapine, mesoridazine, perphenazine, lfluphenazine, promazine, trifluoperazine;&#xD;
             anti-emetics: prochlorperazine, thioridazine, promethazine, mesoridazine,&#xD;
             theiethylperazine, perphazine, dolasetron, dronabinol, droperidol; anti-infective&#xD;
             agents: erythromycin, clarithromycin, troleandomycin, norfloxcin, quinine sulfate,&#xD;
             quinupristin and dalfopristin, pentamidine, sparfloxacin, grepafloxacin, azithromycin,&#xD;
             ofloxacin, levofloxacin; anti-fungal agents: fluconazole, itraconazole, ketoconazole,&#xD;
             miconazole, terconazole, ticonazole, butaconazole; antivirals: foscarnet; protease&#xD;
             inhibitors: indinavir, amprenavir, ritonavir, nelfinavir, squinavir;&#xD;
             antihypertensives: nicardipine, isradipine, moexipril/HCTZ; calcium channel blockers:&#xD;
             verapamil, diltiazem, deltiazem/enalapril, verapamil/trandolapril, tocainide,&#xD;
             bepridil; anti-arrhythmics: disopyramide, quinidine, procainamide, flecainide,&#xD;
             sotalol, bretylium, amiodarone, ibutilide, moricizine; diueretics: bumetanide,&#xD;
             furosemide, torsemide, etharcrynic acid, chlorothiazide, indapamide; antilipemics:&#xD;
             probucol, bepridil, mibefradil; hematological agents: cilostazol; respiratory agents:&#xD;
             zafirlukast, salmetrol; gastrointestinal agents: cimetidine, cisapride; antidiarrheal:&#xD;
             octreotide; antihistamines: azelastine, clemastine; migraine treatment: naratriptan,&#xD;
             sumatriptan, zolmitriptan; antimalarial: halofantrine; muscle relaxants: tizanidine;&#xD;
             narcotic dependence: levomethadyl; miscellaneous: tamoxifen, warfarin, phenytoin,&#xD;
             ziprasidone, risperidone, formoterol fumarate, sildenafil; drugs that prolong the QT&#xD;
             Interval: albuterol, alfuzosin, amantadine, amisulpride, amphetamine, arsenic&#xD;
             trioxide, astemizole, atazanavir, atomoxetine, chloral hydrate, chloroquine,&#xD;
             ciprofloxacin, citalopram, clozapine, cocaine, dexmethylphenidate, diphenhydramine,&#xD;
             dobutamine, dofetilide, dopamine, dronedarone, ephedrine, epinephrine, eribulin,&#xD;
             escitalopram, famotidine, felbamate, fenfluramine, fingolimod, fosphenytoin,&#xD;
             galantamine, gatifloxacin, gemifloxacin, granisetron, iloperidone, isoproterenol,&#xD;
             lapatinib, levalbuterol, lisdexamfetamine, lithium, metaproterenol, methadone,&#xD;
             methylphenidate, midodrine, moxifloxacin, nilotinib, norepinephrine, ondansetron,&#xD;
             oxytocin, paliperidone, perflutren lipid microspheres, phentermine, phenylephrine,&#xD;
             phenylpropanolamine, protriptyline, pseudoephedrine, ranolazine, ritodrine,&#xD;
             toxithromycin, sibutramine, solifenacin, sunitinib, tacrolimus, telithromycin,&#xD;
             terbutaline, terfenadine, tolterodine, trimethoprim-sulfa, vandetanib, vardenafil,&#xD;
             voriconazole.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <results_first_submitted>October 24, 2016</results_first_submitted>
  <results_first_submitted_qc>October 24, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 19, 2016</results_first_posted>
  <last_update_submitted>February 7, 2018</last_update_submitted>
  <last_update_submitted_qc>February 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Ron Schey</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>gastroparesis</keyword>
  <keyword>domperidone</keyword>
  <keyword>nausea</keyword>
  <keyword>vomiting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Domperidone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Domperidone</title>
          <description>Participants will received domperidone at a dose of 10mg given up to three times per day&#xD;
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Domperidone</title>
          <description>Participants will received domperidone at a dose of 10mg given up to three times per day&#xD;
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Improvement of Overall Symptoms Based on Likert Scale</title>
        <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
        <time_frame>Baseline and End of study (2 years or last visit if patient withdraws)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Domperidone</title>
            <description>Participants will received domperidone at a dose of 10mg given up to three times per day&#xD;
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement of Overall Symptoms Based on Likert Scale</title>
          <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement of Nausea Based on Likert Scale</title>
        <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
        <time_frame>Baseline and End of study (2 years or last visit if patient withdraws)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Domperidone</title>
            <description>Participants will received domperidone at a dose of 10mg given up to three times per day&#xD;
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement of Nausea Based on Likert Scale</title>
          <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement of Vomiting Based on Likert Scale</title>
        <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
        <time_frame>Baseline and End of study (2 years or last visit if patient withdraws)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Domperidone</title>
            <description>Participants will received domperidone at a dose of 10mg given up to three times per day&#xD;
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement of Vomiting Based on Likert Scale</title>
          <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement of Abdominal Bloating or Distention Based on Likert Scale</title>
        <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
        <time_frame>Baseline and End of study (2 years or last visit if patient withdraws)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Domperidone</title>
            <description>Participants will received domperidone at a dose of 10mg given up to three times per day&#xD;
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement of Abdominal Bloating or Distention Based on Likert Scale</title>
          <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale</title>
        <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
        <time_frame>Baseline and End of study (2 years or last visit if patient withdraws)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Domperidone</title>
            <description>Participants will received domperidone at a dose of 10mg given up to three times per day&#xD;
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale</title>
          <description>A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Domperidone</title>
          <description>Participants will received domperidone at a dose of 10mg given up to three times per day&#xD;
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Partial Bowel Obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Heartburn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Elevated ALT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Elevated AST</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Shaking</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Shoulder Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hand Tingling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ruptured Right Ovarian Cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Shortness of Breath</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic Reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Ron Schey</name_or_title>
      <organization>University of Iowa</organization>
      <phone>3193849756</phone>
      <email>ron-schey@uiowa.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01711918
org study id: Domperidone
nct id: NCT01711918
lead sponsor: 
has dmc: No
To provide oral domperidone to patients between the ages of 18 and 60 years of age, according
      to the investigator's judgment, a prokinetic effect is needed for the relief of severe
      gastroparesis. We have defined severe gastroparesis as 1) positive gastric emptying
      scintigraphy (more than 10% residue at 4 hours), 2) nausea, 3) early satiety, 4) abdominal
      pain. We will recruit patients for two years and the patients will be given domperidone for
      up to two years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement of Overall Symptoms Based on Likert Scale
time frame: Baseline and End of study (2 years or last visit if patient withdraws)
description: A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
measure: Improvement of Nausea Based on Likert Scale
time frame: Baseline and End of study (2 years or last visit if patient withdraws)
description: A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
measure: Improvement of Vomiting Based on Likert Scale
time frame: Baseline and End of study (2 years or last visit if patient withdraws)
description: A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
measure: Improvement of Abdominal Bloating or Distention Based on Likert Scale
time frame: Baseline and End of study (2 years or last visit if patient withdraws)
description: A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
measure: Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale
time frame: Baseline and End of study (2 years or last visit if patient withdraws)
description: A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
arm group label: Domperidone
arm group type: Experimental
description: Participants will received domperidone at a dose of 10mg given up to three times per day
intervention type: Drug
intervention name: Domperidone
description: oral tablet; dose is 10mg per tablet given up to 3 times daily.
arm group label: Domperidone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Ron Schey
investigator title: Clinical Assistant Professor
mesh term: Gastroparesis
mesh term: Nausea
mesh term: Vomiting
mesh term: Domperidone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 