<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/NCT03244553</url>
  </required_header>
  <id_info>
    <org_study_id>CGMC-Pru-02</org_study_id>
    <nct_id>NCT03244553</nct_id>
  </id_info>
  <brief_title>Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study</brief_title>
  <acronym>IEMPru</acronym>
  <official_title>Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test prucalopride (a prokinetic drug currently approved by Health Canada for&#xD;
      treatment of constipation) as a treatment for Ineffective Esophageal Motility (IEM). Adult&#xD;
      patients with previously diagnosed IEM will be invited to participate by the investigators.&#xD;
      The participants will take the study medication for 5 days and on the final day of medication&#xD;
      undergo an esophageal manometry procedure at the Calgary Gut Motility Centre to measure&#xD;
      esophageal function. Symptoms and side effects will be tracked at baseline and on Day 5.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As part of the standard clinical evaluation of our department, all patients presenting to the&#xD;
      Calgary Gut Motility Centre with dysphagia routinely undergo a thorough clinical assessment&#xD;
      including history taking and physical examination. Depending on their presentation, further&#xD;
      evaluation may include upper endoscopy, barium swallow, esophageal manometry, and pH testing.&#xD;
&#xD;
      Patients meeting inclusion and exclusion criteria will receive prucalopride for 5 days total,&#xD;
      with 2mg on day 1, then 4mg on days 2 to 5. On day 5 of the intervention, patients will&#xD;
      undergo esophageal manometry. Patients will also complete a symptoms questionnaire for&#xD;
      assessment of dysphagia symptoms and the EQ-5D questionnaire for assessment of global quality&#xD;
      of life at baseline and on day 5 of prucalopride treatment.&#xD;
&#xD;
      Full research ethics approval will be obtained prior to commencement of the study.&#xD;
      Participants will be recruited from patients completing esophageal manometry at the South&#xD;
      Health Campus. Patients who have provided consent to be contacted for research studies and&#xD;
      who have dysphagia and findings of ineffective esophageal motility (IEM) on manometry will be&#xD;
      contacted by the study investigators. The results of their esophageal manometry will be&#xD;
      reviewed with them, and the study will be described to them. If the patient is interested in&#xD;
      study participation, then study investigators will arrange for the patient to come to the&#xD;
      South Health Campus to review the study in detail prior to obtaining informed consent. Thirty&#xD;
      patients will be enrolled in this study.&#xD;
&#xD;
      Patients who meet all inclusion and exclusion criteria will be enrolled. Once enrolled, the&#xD;
      participants will be asked to complete a symptom and quality of life questionnaire. They will&#xD;
      receive the prucalopride pills, to be taken for 5 days with the following instructions: Day&#xD;
      1, take 1 tablet (2 mg), on days 2 through 4, take 2 tablets (4mg) and on day 5, take 2&#xD;
      tablets 1 hour prior to the second scheduled study appointment. On day 5, the patient will be&#xD;
      scheduled at South Health Campus for esophageal manometry. Patients will also be asked to&#xD;
      complete a post-treatment symptom and quality of life questionnaire at that time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2017</start_date>
  <completion_date type="Actual">December 2, 2019</completion_date>
  <primary_completion_date type="Actual">December 2, 2019</primary_completion_date>
  <phase>Phase 2</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>Change in number of successful swallows</measure>
    <time_frame>Baseline and on day 5 of treatment</time_frame>
    <description>Esophageal Manometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Dysphagia Questionnaire Score</measure>
    <time_frame>Baseline and on day 5 of treatment</time_frame>
    <description>Mayo 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EQ-5D Score</measure>
    <time_frame>Baseline and on day 5 of treatment</time_frame>
    <description>Quality of life/health related</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Ineffective Esophageal Motility</condition>
  <condition>Dysphagia</condition>
  <arm_group>
    <arm_group_label>Active intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prucalopride for 5 days. Dosage: day 1 2mg, days 3-5 4mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prucalopride</intervention_name>
    <description>5 day treatment</description>
    <arm_group_label>Active intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptom of dysphagia&#xD;
&#xD;
          -  Esophageal findings consistent with ineffective esophageal motility (IEM), defined as&#xD;
             per the Chicago Classification as ≥50% ineffective swallows. Ineffective swallows&#xD;
             include both failed swallows, defined by an average distal contractile integral (DCI)&#xD;
             &lt;100mmHg*cm*sec, and weak swallows, defined by an average DCI &gt;100 but &lt;450mmHg*cm*sec&#xD;
&#xD;
          -  Normal endoscopy&#xD;
&#xD;
          -  If female of childbearing potential, a negative urine pregnancy test administered 1&#xD;
             day prior to taking the study medication (prucalopride)&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical evidence (on history, physical exam, or investigations) of significant&#xD;
             cardiovascular, respiratory, gastrointestinal, hepatic, hematological, renal,&#xD;
             neurological, or psychiatric comorbidities that may interfere with the objectives of&#xD;
             the study and/or pose safety concerns, including pregnancy and breastfeeding&#xD;
&#xD;
          -  History of cardiovascular disorder including myocardial infarction, life-threatening&#xD;
             arrhythmias, pacemaker or defibrillator&#xD;
&#xD;
          -  Estimated GFR &lt;30, documented within 6 months preceding study entry&#xD;
&#xD;
          -  Blood electrolytes (Na, K, CL) measured within past 6 months outside of normal&#xD;
             reference ranges&#xD;
&#xD;
          -  Uncontrolled gastroesophageal reflux disease on pH testing (DeMeester score &gt;14.7)&#xD;
&#xD;
          -  Established esophageal motility disorder, including but not limited to achalasia,&#xD;
             spastic disorders, Esophagogastric junction (EGJ) outflow obstruction, and absent&#xD;
             contractility&#xD;
&#xD;
          -  History of gastrointestinal surgery, including hiatal hernia repair and/or&#xD;
             fundoplication, or any major surgery in the 3 months preceding study entry&#xD;
&#xD;
          -  Use of narcotics or prokinetic treatments that cannot be stopped prior to study entry&#xD;
&#xD;
          -  Use of laxatives that cannot be stopped prior to study entry&#xD;
&#xD;
          -  Use of tricyclic antidepressants at a dose of &gt;25 mg daily (stable doses of SSRIs/&#xD;
             SNRIs are permitted)&#xD;
&#xD;
          -  Use of macrolide antibiotics (non-macrolide antibiotics are permitted)&#xD;
&#xD;
          -  Participation in clinical trial with prokinetic treatment in the 30 days preceding&#xD;
             study entry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle Buresi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 1N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Michelle Buresi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prucalopride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03244553
org study id: CGMC-Pru-02
nct id: NCT03244553
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will test prucalopride (a prokinetic drug currently approved by Health Canada for
      treatment of constipation) as a treatment for Ineffective Esophageal Motility (IEM). Adult
      patients with previously diagnosed IEM will be invited to participate by the investigators.
      The participants will take the study medication for 5 days and on the final day of medication
      undergo an esophageal manometry procedure at the Calgary Gut Motility Centre to measure
      esophageal function. Symptoms and side effects will be tracked at baseline and on Day 5.
As part of the standard clinical evaluation of our department, all patients presenting to the
      Calgary Gut Motility Centre with dysphagia routinely undergo a thorough clinical assessment
      including history taking and physical examination. Depending on their presentation, further
      evaluation may include upper endoscopy, barium swallow, esophageal manometry, and pH testing.

      Patients meeting inclusion and exclusion criteria will receive prucalopride for 5 days total,
      with 2mg on day 1, then 4mg on days 2 to 5. On day 5 of the intervention, patients will
      undergo esophageal manometry. Patients will also complete a symptoms questionnaire for
      assessment of dysphagia symptoms and the EQ-5D questionnaire for assessment of global quality
      of life at baseline and on day 5 of prucalopride treatment.

      Full research ethics approval will be obtained prior to commencement of the study.
      Participants will be recruited from patients completing esophageal manometry at the South
      Health Campus. Patients who have provided consent to be contacted for research studies and
      who have dysphagia and findings of ineffective esophageal motility (IEM) on manometry will be
      contacted by the study investigators. The results of their esophageal manometry will be
      reviewed with them, and the study will be described to them. If the patient is interested in
      study participation, then study investigators will arrange for the patient to come to the
      South Health Campus to review the study in detail prior to obtaining informed consent. Thirty
      patients will be enrolled in this study.

      Patients who meet all inclusion and exclusion criteria will be enrolled. Once enrolled, the
      participants will be asked to complete a symptom and quality of life questionnaire. They will
      receive the prucalopride pills, to be taken for 5 days with the following instructions: Day
      1, take 1 tablet (2 mg), on days 2 through 4, take 2 tablets (4mg) and on day 5, take 2
      tablets 1 hour prior to the second scheduled study appointment. On day 5, the patient will be
      scheduled at South Health Campus for esophageal manometry. Patients will also be asked to
      complete a post-treatment symptom and quality of life questionnaire at that time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in number of successful swallows
time frame: Baseline and on day 5 of treatment
description: Esophageal Manometry
measure: Change in Dysphagia Questionnaire Score
time frame: Baseline and on day 5 of treatment
description: Mayo 30
measure: Change in EQ-5D Score
time frame: Baseline and on day 5 of treatment
description: Quality of life/health related
arm group label: Active intervention
arm group type: Experimental
description: Prucalopride for 5 days. Dosage: day 1 2mg, days 3-5 4mg
intervention type: Drug
intervention name: Prucalopride
description: 5 day treatment
arm group label: Active intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Michelle Buresi, MD, PhD
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Michelle Buresi
investigator title: Principal Investigator
mesh term: Deglutition Disorders
mesh term: Prucalopride
sharing ipd: No