<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/NCT02212821</url>
  </required_header>
  <id_info>
    <org_study_id>Erythromycin_v6</org_study_id>
    <nct_id>NCT02212821</nct_id>
  </id_info>
  <brief_title>Brain Mechanisms Underlying the Effect of the Motilin Receptor Agonist Erythromycin on Hunger in Normal Weight Subjects</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on&#xD;
      hunger, and the brain mechanism lying behind it.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional brain images</measure>
    <time_frame>40 min after intervention</time_frame>
    <description>The functional brain images will be taken via functional magnetic resonance imaging (fMRI), and be analysed via a software called SPM.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hunger scores</measure>
    <time_frame>every 10 minutes since the scan starts</time_frame>
    <description>The hunger scores will be taken every 10 minutes since the scan starts via a 10 cm visual analogue scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gut hormones</measure>
    <time_frame>every 10 min since the scan starts</time_frame>
    <description>Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure gut hormones (motilin, ghrelin, CCK, PYY, GLP-1) by radioimmuno-assay.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Erythromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravenous infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erythromycin</intervention_name>
    <arm_group_label>Erythromycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>physiological saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female only.&#xD;
&#xD;
          -  Age &gt; 18 and &lt; 60.&#xD;
&#xD;
          -  Body Mass Index (BMI) of 19-25 kg/m2 (no weight change of more than 5 kg in the past&#xD;
             three months).&#xD;
&#xD;
          -  Not known to have any chronic medical illness or illnesses affecting the&#xD;
             gastrointestinal, cardiovascular, or nervous systems, chronic pain or psychiatric&#xD;
             disorder.&#xD;
&#xD;
          -  If female not known to be pregnant.&#xD;
&#xD;
          -  Not known to have any past upper gastrointestinal surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcohol consumption &gt; 7 drinks / week&#xD;
&#xD;
          -  Major depression and chronic health conditions except controlled hypertension&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Tack</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leuven</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>March 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erythromycin</mesh_term>
    <mesh_term>Erythromycin Estolate</mesh_term>
    <mesh_term>Erythromycin Ethylsuccinate</mesh_term>
    <mesh_term>Erythromycin stearate</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/NCT02212821
org study id: Erythromycin_v6
nct id: NCT02212821
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on
      hunger, and the brain mechanism lying behind it.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Functional brain images
time frame: 40 min after intervention
description: The functional brain images will be taken via functional magnetic resonance imaging (fMRI), and be analysed via a software called SPM.
measure: hunger scores
time frame: every 10 minutes since the scan starts
description: The hunger scores will be taken every 10 minutes since the scan starts via a 10 cm visual analogue scale.
measure: gut hormones
time frame: every 10 min since the scan starts
description: Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure gut hormones (motilin, ghrelin, CCK, PYY, GLP-1) by radioimmuno-assay.
arm group label: Placebo
arm group type: Placebo Comparator
description: intravenous infusion
arm group label: Erythromycin
arm group type: Experimental
description: intravenous infusion
intervention type: Drug
intervention name: Erythromycin
arm group label: Erythromycin
intervention type: Drug
intervention name: Placebo
description: physiological saline
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Tack
role: Principal Investigator
affiliation: University of Leuven
responsible party type: Sponsor
mesh term: Erythromycin
mesh term: Erythromycin Estolate
mesh term: Erythromycin Ethylsuccinate
mesh term: Erythromycin stearate