<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/NCT01712204</url>
  </required_header>
  <id_info>
    <org_study_id>AC-201-GOU-001</org_study_id>
    <nct_id>NCT01712204</nct_id>
  </id_info>
  <brief_title>A Proof-of-Concept Study of AC-201 to Prevent Gout Flares</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Trial Of AC-201 In Subjects With Gout Initiating Urate-Lowering Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TWi Biotechnology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TWi Biotechnology, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Initiation of ULT for gout increases the occurrence of acute gouty arthritis flares due to&#xD;
      mobilization of urate from tissue deposits. IL-1β plays a key role in mediating the&#xD;
      inflammatory response in gouty arthritis. The efficacy of IL-1β blockade in the prophylaxis&#xD;
      of gouty flares during initiation of ULT has been validated in multiple trials of IL-1β&#xD;
      inhibitor therapies. Therefore, it is believed that IL-1β is a relevant therapeutic target&#xD;
      for gout flares. AC-201 is an IL-1β modulator indicated for the treatment of osteoarthritis&#xD;
      with good safety record and very few contraindications to the co-morbidities commonly among&#xD;
      gout patients. AC-201 has also been demonstrated to have uric acid-lowering effects in&#xD;
      clinical trials. The favorable product profile of AC-201 overall provides a strong rationale&#xD;
      for investigating its clinical utility as prophylaxis against flares when initiating ULT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical trials have demonstrated that anti-IL-1 agents (IL-1Ra, IL-1 Trap, and anti-IL-1β&#xD;
      monoclonal antibody) can reduce the frequency of gout flares during the initial period of&#xD;
      treatment with urate-lowering therapy and prevent of gout flares in gout patients with&#xD;
      frequent flares. AC-201 is an oral IL-1 modulator but with a mechanism distinct from that of&#xD;
      existing anti-IL-1 agents. The active metabolite of AC-201 has been shown in vitro and in&#xD;
      vivo to inhibit the production and activity of IL-1, down-regulate IL-1 receptors, and&#xD;
      increase IL1-Ra. Molecular research further suggests that these effects are mediated upstream&#xD;
      via inhibition of MAPK signaling pathways and binding of NF-κB and AP-1 transcription factors&#xD;
      that encode for a range of pro-inflammatory factors, including IL-1β, TNF-α, IL-6, IL-8,&#xD;
      iNOS, and MMPs, which have been implicated in gout flares. AC-201 has also been demonstrated&#xD;
      to have uric acid-lowering effects in clinical trials. The favorable product profile of&#xD;
      AC-201 overall provides a strong rationale for investigating its clinical utility as&#xD;
      prophylaxis against flares when initiating ULT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Gout Flares Per Subject</measure>
    <time_frame>16 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Gout Flares</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo plus Febuxostat</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AC-201</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AC-201 plus Febuxostat</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo Capsule BID for 16 Weeks</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>PBO</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AC-201</intervention_name>
    <description>AC-201 50mg Capsule BID for 16 Weeks</description>
    <arm_group_label>AC-201</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Febuxostat</intervention_name>
    <description>Febuxostat 80 mg QD for 16 Weeks</description>
    <arm_group_label>AC-201</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>ULT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female age 20 to 80 years, inclusive&#xD;
&#xD;
          -  Meets at least 6 of the 12 American College of Rheumatology preliminary criteria&#xD;
             (1977) for the classification of acute arthritis of primary gout, OR have proven&#xD;
             tophus or documented monosodium urate (MSU) crystals in the joint fluid&#xD;
&#xD;
          -  Serum uric acid ≥7.5 mg/dL at screening&#xD;
&#xD;
          -  Experienced ≥2 gouty arthritis flares within one year prior to screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Occurrence of a gouty arthritis flare ongoing at screening or during the screening&#xD;
             period through baseline&#xD;
&#xD;
          -  Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 4&#xD;
             weeks prior to screening&#xD;
&#xD;
          -  Use of colchicine, glucocorticoids, NSAIDs, or COX-2 inhibitors within 1 week prior to&#xD;
             screening&#xD;
&#xD;
          -  Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases&#xD;
             with arthritis, or any condition requiring chronic daily use of pain medication&#xD;
&#xD;
          -  History of allergy to any components of study medication, including diacerein&#xD;
&#xD;
          -  Allergy, contraindication, or intolerance to febuxostat&#xD;
&#xD;
          -  Contraindication or allergy to NSAIDs&#xD;
&#xD;
          -  Severe renal impairment&#xD;
&#xD;
          -  Any prior use of biologic anti-inflammatory therapy, such as IL-1 modulators, tumor&#xD;
             necrosis factor inhibitors, IL-6 inhibitors, or T-cell costimulation modulator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <results_first_submitted>November 24, 2014</results_first_submitted>
  <results_first_submitted_qc>November 24, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 1, 2014</results_first_posted>
  <last_update_submitted>April 24, 2018</last_update_submitted>
  <last_update_submitted_qc>April 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prophylaxis of Acute Gout Flares</keyword>
  <keyword>Urate-Lowering Therapy</keyword>
  <keyword>Hyperuricemia</keyword>
  <keyword>Gouty arthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gout</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Febuxostat</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Overall, 82 patients from 8 clinical centers participated in the study between 28 January 2013 to 04 September 2013.</recruitment_details>
      <pre_assignment_details>Participants were assessed at an initial screening visit within 2 weeks before the baseline visit.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo Capsule BID for 16 Weeks</description>
        </group>
        <group group_id="P2">
          <title>AC-201</title>
          <description>AC-201 50mg Capsule BID for 16 Weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>A total of 82 subjects were randomized and received at least one dose of study medication (the Intent-to-Treat [ITT] Population). The ITT Population was used for baseline/demographic, disposition, and safety summaries. The ITT Population was the primary analysis set for efficacy analyses.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo Capsule BID</title>
          <description>Placebo Capsule BID for 16 Weeks</description>
        </group>
        <group group_id="B2">
          <title>AC-201 50mg Capsule BID</title>
          <description>AC-201 50mg Capsule BID for 16 Weeks</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="41"/>
            <count group_id="B2" value="41"/>
            <count group_id="B3" value="82"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.6" spread="11.8"/>
                    <measurement group_id="B2" value="43.7" spread="12.6"/>
                    <measurement group_id="B3" value="43.6" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Gout Flares Per Subject</title>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo Capsule BID for 16 Weeks&#xD;
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)</description>
          </group>
          <group group_id="O2">
            <title>AC-201</title>
            <description>AC-201 50mg Capsule BID for 16 Weeks&#xD;
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Gout Flares Per Subject</title>
          <units>flares</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.02" lower_limit="2.51" upper_limit="3.64"/>
                    <measurement group_id="O2" value="2.45" lower_limit="2.01" upper_limit="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1356</p_value>
            <method>Possion regression</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.81</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.113</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo Capsule BID for 16 Weeks&#xD;
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)</description>
        </group>
        <group group_id="E2">
          <title>AC-201</title>
          <description>AC-201 50mg Capsule BID for 16 Weeks&#xD;
Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Frequent Gout Attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood CPK increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>ALT increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Creatinine renal clearance decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>TWi Biotechnology, Inc.</organization>
      <phone>+886-2-26573350 ext 368</phone>
      <email>Carl.Brown@twipharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01712204
org study id: AC-201-GOU-001
nct id: NCT01712204
lead sponsor: 
has dmc: No
Initiation of ULT for gout increases the occurrence of acute gouty arthritis flares due to
      mobilization of urate from tissue deposits. IL-1β plays a key role in mediating the
      inflammatory response in gouty arthritis. The efficacy of IL-1β blockade in the prophylaxis
      of gouty flares during initiation of ULT has been validated in multiple trials of IL-1β
      inhibitor therapies. Therefore, it is believed that IL-1β is a relevant therapeutic target
      for gout flares. AC-201 is an IL-1β modulator indicated for the treatment of osteoarthritis
      with good safety record and very few contraindications to the co-morbidities commonly among
      gout patients. AC-201 has also been demonstrated to have uric acid-lowering effects in
      clinical trials. The favorable product profile of AC-201 overall provides a strong rationale
      for investigating its clinical utility as prophylaxis against flares when initiating ULT.
Clinical trials have demonstrated that anti-IL-1 agents (IL-1Ra, IL-1 Trap, and anti-IL-1β
      monoclonal antibody) can reduce the frequency of gout flares during the initial period of
      treatment with urate-lowering therapy and prevent of gout flares in gout patients with
      frequent flares. AC-201 is an oral IL-1 modulator but with a mechanism distinct from that of
      existing anti-IL-1 agents. The active metabolite of AC-201 has been shown in vitro and in
      vivo to inhibit the production and activity of IL-1, down-regulate IL-1 receptors, and
      increase IL1-Ra. Molecular research further suggests that these effects are mediated upstream
      via inhibition of MAPK signaling pathways and binding of NF-κB and AP-1 transcription factors
      that encode for a range of pro-inflammatory factors, including IL-1β, TNF-α, IL-6, IL-8,
      iNOS, and MMPs, which have been implicated in gout flares. AC-201 has also been demonstrated
      to have uric acid-lowering effects in clinical trials. The favorable product profile of
      AC-201 overall provides a strong rationale for investigating its clinical utility as
      prophylaxis against flares when initiating ULT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Number of Gout Flares Per Subject
time frame: 16 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo plus Febuxostat
arm group label: AC-201
arm group type: Experimental
description: AC-201 plus Febuxostat
intervention type: Drug
intervention name: Placebo
description: Placebo Capsule BID for 16 Weeks
arm group label: Placebo
other name: PBO
intervention type: Drug
intervention name: AC-201
description: AC-201 50mg Capsule BID for 16 Weeks
arm group label: AC-201
intervention type: Drug
intervention name: Febuxostat
description: Febuxostat 80 mg QD for 16 Weeks
arm group label: AC-201
arm group label: Placebo
other name: ULT
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Gout
mesh term: Febuxostat
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 