<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/NCT03784105</url>
  </required_header>
  <id_info>
    <org_study_id>S60496</org_study_id>
    <nct_id>NCT03784105</nct_id>
  </id_info>
  <brief_title>Codeine on Pharyngeal and Esophageal Motility</brief_title>
  <official_title>Effect of Codeine on Pharyngeal and Esophageal Motility in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Opioids act on opioid receptors located in the brain as well as in the gastrointestinal (GI)&#xD;
      tract to induce changes in motility. A variety of studies have linked chronic opioid use with&#xD;
      changes in intestinal and to a lesser extent esophageal motility. Less is known about acute&#xD;
      administration effects on distal esophageal motility and LES and even less with respect to&#xD;
      proximal esophagus, UES and pharynx. Codeine, an opioid receptor agonist, by acting both&#xD;
      centrally as well as in the periphery may induce changes in parts of the GI tract implicated&#xD;
      in deglutition. Therefore, to evaluate the hypothesis the researchers will study motility&#xD;
      patterns in the pharynx, UES, proximal and distal esophagus and LES in 22 healthy volunteers&#xD;
      receiving placebo or codeine (60 mg) in a double-blind randomized cross-over controlled&#xD;
      fashion. Motility patterns will be studied using state-of-the-art criteria and analytic tools&#xD;
      (Chicago 3.0, AIMPlot analysis).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">December 14, 2018</completion_date>
  <primary_completion_date type="Actual">December 14, 2018</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>
    <intervention_model_description>Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blind, preparation and administration of codeine or placebo conducted by an independent researcher.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in distal contractile integral</measure>
    <time_frame>1 week</time_frame>
    <description>The difference in distal contractile integral between the codeine and placebo condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in integrated relaxation pressure</measure>
    <time_frame>1 week</time_frame>
    <description>The difference in integrated relaxation pressure between the codeine and placebo condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in distal latency</measure>
    <time_frame>1 week</time_frame>
    <description>The difference in distal latency between the codeine and placebo condition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in pressure flow</measure>
    <time_frame>1 week</time_frame>
    <description>The difference in pressure flow between the codeine and placebo condition</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Esophageal Motility Disorders</condition>
  <arm_group>
    <arm_group_label>Codeine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Siripus simplex</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Codeine Phosphate</intervention_name>
    <description>30 mL of codeine phosphate 10mg/5mL</description>
    <arm_group_label>Codeine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Siripus simplex</intervention_name>
    <description>Sugar syrup</description>
    <arm_group_label>Siripus simplex</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers aged between 18-60 years old&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No chronic disease/medication&#xD;
&#xD;
          -  No GI symptoms&#xD;
&#xD;
          -  Not pregnant or breast-feeding&#xD;
&#xD;
          -  No history of head/neck surgery&#xD;
&#xD;
          -  Not allergic to codeine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jan Tack</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>codeine</keyword>
  <keyword>Esophageal motility</keyword>
  <keyword>Pharyngeal motility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Motility Disorders</mesh_term>
    <mesh_term>Esophageal Spasm, Diffuse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Codeine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03784105
org study id: S60496
nct id: NCT03784105
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Opioids act on opioid receptors located in the brain as well as in the gastrointestinal (GI)
      tract to induce changes in motility. A variety of studies have linked chronic opioid use with
      changes in intestinal and to a lesser extent esophageal motility. Less is known about acute
      administration effects on distal esophageal motility and LES and even less with respect to
      proximal esophagus, UES and pharynx. Codeine, an opioid receptor agonist, by acting both
      centrally as well as in the periphery may induce changes in parts of the GI tract implicated
      in deglutition. Therefore, to evaluate the hypothesis the researchers will study motility
      patterns in the pharynx, UES, proximal and distal esophagus and LES in 22 healthy volunteers
      receiving placebo or codeine (60 mg) in a double-blind randomized cross-over controlled
      fashion. Motility patterns will be studied using state-of-the-art criteria and analytic tools
      (Chicago 3.0, AIMPlot analysis).
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Double-blind, preparation and administration of codeine or placebo conducted by an independent researcher.
measure: Difference in distal contractile integral
time frame: 1 week
description: The difference in distal contractile integral between the codeine and placebo condition
measure: Difference in integrated relaxation pressure
time frame: 1 week
description: The difference in integrated relaxation pressure between the codeine and placebo condition
measure: Difference in distal latency
time frame: 1 week
description: The difference in distal latency between the codeine and placebo condition.
measure: Difference in pressure flow
time frame: 1 week
description: The difference in pressure flow between the codeine and placebo condition
arm group label: Codeine
arm group type: Experimental
arm group label: Siripus simplex
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Codeine Phosphate
description: 30 mL of codeine phosphate 10mg/5mL
arm group label: Codeine
intervention type: Drug
intervention name: Siripus simplex
description: Sugar syrup
arm group label: Siripus simplex
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Esophageal Motility Disorders
mesh term: Esophageal Spasm, Diffuse
mesh term: Codeine
sharing ipd: Undecided