<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/NCT02233699</url>
  </required_header>
  <id_info>
    <org_study_id>XEN-D0501-CL-04</org_study_id>
    <nct_id>NCT02233699</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With Chronic Idiopathic Cough</brief_title>
  <official_title>A Double-blind, Randomised, Placebo-controlled, Crossover Study to Assess the Efficacy of XEN-D0501, a Transient Receptor Potential Vanilloid Receptor 1 (TRPV1) Antagonist, in Reducing the Frequency of Cough in Patients With Chronic Idiopathic Cough.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xention Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ario Pharma Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Xention Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in&#xD;
      reducing the daytime cough frequency in patients with chronic idiopathic cough.&#xD;
&#xD;
      The effectiveness of XEN-D0501 over placebo in reducing capsaicin cough responses, objective&#xD;
      24-hour cough frequency, hourly change in cough frequency, cough severity (via visual&#xD;
      analogue scale [VAS]), urge to cough (via VAS), global rating of change scale and Leicester&#xD;
      Cough Questionnaire (LCQ) will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline at the end of each treatment period in objective daytime cough frequency on XEN-D0501 compared to placebo</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Chronic Idiopathic Cough</condition>
  <arm_group>
    <arm_group_label>XEN-D0501</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4mg BID Days 1-13, 4mg once daily (OD) Day 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to Match</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>BID Days 1-13, once daily (OD) Day 14</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XEN-D0501</intervention_name>
    <arm_group_label>XEN-D0501</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo to Match</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male/female subjects aged 18 or over with chronic idiopathic cough&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant medical history&#xD;
&#xD;
          -  Abnormal laboratory results, ECGs or vital signs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Belfast City Hospital</name>
      <address>
        <city>Belfast</city>
        <zip>BT9 7AB</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of South Manchester</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>July 14, 2015</last_update_submitted>
  <last_update_submitted_qc>July 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2015</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>Cough</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/NCT02233699
org study id: XEN-D0501-CL-04
nct id: NCT02233699
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in
      reducing the daytime cough frequency in patients with chronic idiopathic cough.

      The effectiveness of XEN-D0501 over placebo in reducing capsaicin cough responses, objective
      24-hour cough frequency, hourly change in cough frequency, cough severity (via visual
      analogue scale [VAS]), urge to cough (via VAS), global rating of change scale and Leicester
      Cough Questionnaire (LCQ) will be evaluated.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline at the end of each treatment period in objective daytime cough frequency on XEN-D0501 compared to placebo
time frame: 12 weeks
arm group label: XEN-D0501
arm group type: Experimental
description: 4mg BID Days 1-13, 4mg once daily (OD) Day 14
arm group label: Placebo to Match
arm group type: Placebo Comparator
description: BID Days 1-13, once daily (OD) Day 14
intervention type: Drug
intervention name: XEN-D0501
arm group label: XEN-D0501
intervention type: Drug
intervention name: Placebo
arm group label: Placebo to Match
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Ireland
country: United Kingdom
responsible party type: Sponsor
mesh term: Cough