<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/NCT02190786</url>
  </required_header>
  <id_info>
    <org_study_id>KUX1201</org_study_id>
    <nct_id>NCT02190786</nct_id>
  </id_info>
  <brief_title>Phase II Exploratory Clinical Study of KUX-1151</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kissei Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kissei Pharmaceutical Co., Ltd.</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of&#xD;
      multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Proportion of subjects achieving serum uric acid level ≤ 6 mg/dL</measure>
    <time_frame>14 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent change from baseline in serum uric acid level</measure>
    <time_frame>14 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in serum uric acid level</measure>
    <time_frame>14 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <condition>Hyperuricemia</condition>
  <arm_group>
    <arm_group_label>KUX-1151, Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>KUX-1151, Middle dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>KUX-1151, High dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KUX-1151</intervention_name>
    <arm_group_label>KUX-1151, High dose</arm_group_label>
    <arm_group_label>KUX-1151, Low dose</arm_group_label>
    <arm_group_label>KUX-1151, Middle dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Japanese HU patients (Outpatient)&#xD;
&#xD;
          -  Patients who meet the following criteria concerning serum uric acid levels at the&#xD;
             screening [1) Gout: &gt; 7.0 mg/dL, 2) HU with complications: ≥ 8.0 mg/dL, 3) HU without&#xD;
             complications: ≥ 9.0 mg/dL]&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have any symptom of gouty arthritis within 2 weeks of investigational&#xD;
             product administration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Tokyo and Other Japanese City</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>October 16, 2015</last_update_submitted>
  <last_update_submitted_qc>October 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hyperuricemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperuricemia</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/NCT02190786
org study id: KUX1201
nct id: NCT02190786
lead sponsor: 
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of
      multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.
measure: Proportion of subjects achieving serum uric acid level ≤ 6 mg/dL
time frame: 14 weeks
measure: Percent change from baseline in serum uric acid level
time frame: 14 weeks
measure: Change from baseline in serum uric acid level
time frame: 14 weeks
arm group label: KUX-1151, Low dose
arm group type: Experimental
arm group label: KUX-1151, Middle dose
arm group type: Experimental
arm group label: KUX-1151, High dose
arm group type: Experimental
intervention type: Drug
intervention name: KUX-1151
arm group label: KUX-1151, High dose
arm group label: KUX-1151, Low dose
arm group label: KUX-1151, Middle dose
criteria: 
gender: All
minimum age: 20 Years
maximum age: 64 Years
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Hyperuricemia