<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/NCT01705275</url>
  </required_header>
  <id_info>
    <org_study_id>ONO-8539POE012</org_study_id>
    <nct_id>NCT01705275</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Effect of ONO-8539 on Acid-Induced Oesophageal Hypersensitivity in Healthy Volunteers</brief_title>
  <official_title>A Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Acid-induced Oesophageal Hypersensitivity in Healthy Male Adult Volunteers</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 study to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity&#xD;
      in healthy male adult volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomised, double-blind, placebo-controlled, two-period crossover study, to&#xD;
      investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity in healthy&#xD;
      male adult volunteers. Each subject will be randomised to ONO-8539 or placebo twice daily in&#xD;
      the first treatment period and the alternate treatment in the second treatment period. Dosing&#xD;
      in each period will be for 15 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <primary_completion_date type="Actual">March 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>Area under the curve (AUC) of the change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.</measure>
    <time_frame>15 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the Curve (AUC) of the change from baseline in pain threshold in the distal oesophagus following electrical stimulation after oesophageal acid infusion</measure>
    <time_frame>15 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum change from baseline in pain threshold in the proximal and distal oesophagus following electrical stimulation after oesophageal acid infusion.</measure>
    <time_frame>15 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in absolute pain threshold from baseline in the proximal and distal oesophagus and somatic control following electrical stimulation after oesophageal acid infusion at each time point.</measure>
    <time_frame>15 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline at each time point in subject reported pain following electrical stimulation after oesophageal acid infusion using the short-form McGill pain questionnaire (SF-MPQ).</measure>
    <time_frame>15 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between the pharmacokinetics of ONO-8539 and change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.</measure>
    <time_frame>15 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between State Trait Anxiety Inventory (STAI)-state score and change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.</measure>
    <time_frame>15 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability: adverse events, physical examination, body weight, vital signs, 12-lead Electrocardiogram (ECG) and safety laboratory evaluations.</measure>
    <time_frame>15 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The maximum observed plasma concentrations (Cmax), time to reach Cmax (Tmax), area under the curve (AUC), and trough concentration of ONO-8539 prior to dosing.</measure>
    <time_frame>15 Days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Acid Reflux</condition>
  <arm_group>
    <arm_group_label>ONO-8539 BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ONO-8539</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo BID</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ONO-8539</intervention_name>
    <description>ONO-8539</description>
    <arm_group_label>ONO-8539 BID</arm_group_label>
    <other_name>ONO-8539 acid hypersensitivity</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Identical to ONO-8539 tablet but without active ingedient</description>
    <arm_group_label>Placebo BID</arm_group_label>
    <other_name>0mg ONO-8539</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Caucasian male subjects, aged 18-45 years inclusive, will be entered into this&#xD;
             study.&#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.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>London Clinical site Recruiting</name>
      <address>
        <city>London</city>
        <zip>E1 2AJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>July 4, 2014</last_update_submitted>
  <last_update_submitted_qc>July 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT01705275
org study id: ONO-8539POE012
nct id: NCT01705275
lead sponsor: 
has dmc: No
A study to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity
      in healthy male adult volunteers.
This is a randomised, double-blind, placebo-controlled, two-period crossover study, to
      investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity in healthy
      male adult volunteers. Each subject will be randomised to ONO-8539 or placebo twice daily in
      the first treatment period and the alternate treatment in the second treatment period. Dosing
      in each period will be for 15 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Area under the curve (AUC) of the change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.
time frame: 15 days
measure: Area under the Curve (AUC) of the change from baseline in pain threshold in the distal oesophagus following electrical stimulation after oesophageal acid infusion
time frame: 15 days
measure: Maximum change from baseline in pain threshold in the proximal and distal oesophagus following electrical stimulation after oesophageal acid infusion.
time frame: 15 days
measure: Change in absolute pain threshold from baseline in the proximal and distal oesophagus and somatic control following electrical stimulation after oesophageal acid infusion at each time point.
time frame: 15 Days
measure: Change from baseline at each time point in subject reported pain following electrical stimulation after oesophageal acid infusion using the short-form McGill pain questionnaire (SF-MPQ).
time frame: 15 Days
measure: Relationship between the pharmacokinetics of ONO-8539 and change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.
time frame: 15 Days
measure: Relationship between State Trait Anxiety Inventory (STAI)-state score and change from baseline in pain threshold in the proximal oesophagus following electrical stimulation after oesophageal acid infusion.
time frame: 15 Days
measure: Safety and tolerability: adverse events, physical examination, body weight, vital signs, 12-lead Electrocardiogram (ECG) and safety laboratory evaluations.
time frame: 15 Days
measure: The maximum observed plasma concentrations (Cmax), time to reach Cmax (Tmax), area under the curve (AUC), and trough concentration of ONO-8539 prior to dosing.
time frame: 15 Days
arm group label: ONO-8539 BID
arm group type: Experimental
description: ONO-8539
arm group label: Placebo BID
arm group type: Placebo Comparator
description: 0mg
intervention type: Drug
intervention name: ONO-8539
description: ONO-8539
arm group label: ONO-8539 BID
other name: ONO-8539 acid hypersensitivity
intervention type: Other
intervention name: Placebo
description: Identical to ONO-8539 tablet but without active ingedient
arm group label: Placebo BID
other name: 0mg ONO-8539
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Study Director
role: Study Director
affiliation: Clinical Department, Ono Pharmaceutical Co. Ltd
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Hypersensitivity