<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/NCT01707901</url>
  </required_header>
  <id_info>
    <org_study_id>ONO-8539POE011</org_study_id>
    <nct_id>NCT01707901</nct_id>
  </id_info>
  <brief_title>A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease</brief_title>
  <official_title>A Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ono Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ono Pharmaceutical Co. Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal&#xD;
      pain hypersensitivity in patients with gastric reflux disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to&#xD;
      Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With&#xD;
      Non-erosive Reflux Disease&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion</measure>
    <time_frame>28 Days</time_frame>
    <description>Daily, through a pain assessment score chart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD</measure>
    <time_frame>28 Days</time_frame>
    <description>Daily, by observation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the tolerability of ONO-8539</measure>
    <time_frame>28 Days</time_frame>
    <description>Daily, through observation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation</measure>
    <time_frame>28 Days</time_frame>
    <description>Daily, through observation and a pain score chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the effect of ONO-8539 on quality of life</measure>
    <time_frame>28 Days</time_frame>
    <description>Daily, through Quality of life assessment questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To investigate the pharmacokinetics of ONO-8539</measure>
    <time_frame>28 Days</time_frame>
    <description>AUC, Cmax, Tmax&#xD;
Concentrations of ONO-8539</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To investigate the association among the changes in pharmacodynamics of ONO-8539</measure>
    <time_frame>28 Days</time_frame>
    <description>Daily observation and through Quality of life assessment questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To investigate the association between the changes in pharmacodynamic parameters of ONO-8539 and the plasma concentrations of ONO-8539</measure>
    <time_frame>28 Days</time_frame>
    <description>Correlation between pharmacokinetic results and study specific procedure results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the use of antacid in each treatment group</measure>
    <time_frame>28 Days</time_frame>
    <description>Daily record of frequency of use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the safety of ONO-8539</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To investigate the association among the changes in psychological parameters of ONO-8539</measure>
    <time_frame>28 days</time_frame>
    <description>Psychological parameters</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>GERD</condition>
  <arm_group>
    <arm_group_label>ONO-8539</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ONO-8539</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ONO-8539</intervention_name>
    <description>Treatment</description>
    <arm_group_label>ONO-8539</arm_group_label>
    <other_name>Experimental</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects aged 18-70 years inclusive with confirmed GERD and normal&#xD;
             oesophageal mucosa will be enrolled in this study. Subjects demonstrate moderate&#xD;
             intensity heartburn while being on a stable dose of proton pump inhibitor and&#xD;
             demonstrate oesophageal hypersensitivity following distal oesophageal acid perfusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will be excluded if they have a motility disorder, are not able to tolerate&#xD;
             study procedures or have had GI surgery or have a condition that would affect the&#xD;
             study results. Subjects with functional heartburn, acute GI symptoms, endoscopic or&#xD;
             manometric abnormality or a protocol-specified cardiovascular condition will not be&#xD;
             enrolled.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Clinical Department, Ono Pharmaceutical Co. Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leuven Clinical site</name>
      <address>
        <city>Leuven</city>
        <zip>B-3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Clinical site</name>
      <address>
        <city>London</city>
        <zip>E1 2AJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 13, 2015</last_update_submitted>
  <last_update_submitted_qc>October 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GERD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_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/NCT01707901
org study id: ONO-8539POE011
nct id: NCT01707901
lead sponsor: 
has dmc: No
A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal
      pain hypersensitivity in patients with gastric reflux disease
This is a Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to
      Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With
      Non-erosive Reflux Disease
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: To evaluate the effect of ONO-8539 on oesophageal pain hypersensitivity to acid perfusion
time frame: 28 Days
description: Daily, through a pain assessment score chart
measure: To evaluate the effect of ONO-8539 on subject-reported symptoms of GERD
time frame: 28 Days
description: Daily, by observation
measure: To assess the tolerability of ONO-8539
time frame: 28 Days
description: Daily, through observation
measure: To investigate the effect of ONO-8539 on oesophageal pain hypersensitivity to electrical stimulation
time frame: 28 Days
description: Daily, through observation and a pain score chart
measure: To evaluate the effect of ONO-8539 on quality of life
time frame: 28 Days
description: Daily, through Quality of life assessment questionnaires
measure: To investigate the pharmacokinetics of ONO-8539
time frame: 28 Days
description: AUC, Cmax, Tmax
Concentrations of ONO-8539
measure: To investigate the association among the changes in pharmacodynamics of ONO-8539
time frame: 28 Days
description: Daily observation and through Quality of life assessment questionnaires
measure: To investigate the association between the changes in pharmacodynamic parameters of ONO-8539 and the plasma concentrations of ONO-8539
time frame: 28 Days
description: Correlation between pharmacokinetic results and study specific procedure results
measure: To evaluate the use of antacid in each treatment group
time frame: 28 Days
description: Daily record of frequency of use
measure: To assess the safety of ONO-8539
time frame: 28 days
measure: To investigate the association among the changes in psychological parameters of ONO-8539
time frame: 28 days
description: Psychological parameters
arm group label: ONO-8539
arm group type: Experimental
description: ONO-8539
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: ONO-8539
description: Treatment
arm group label: ONO-8539
other name: Experimental
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Clinical Department, Ono Pharmaceutical Co. Ltd
facility: 
facility: 
country: Belgium
country: United Kingdom
responsible party type: Sponsor
mesh term: Hypersensitivity