xml: <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/NCT06042192</url>
    </required_header>
    <id_info>
      <org_study_id>TK-254RX-0106</org_study_id>
      <nct_id>NCT06042192</nct_id>
    </id_info>
    <brief_title>Open Label Trial to Evaluate the Adhesion of TK-254RX in Healthy Volunteers.</brief_title>
    <official_title>Open Label Trial to Evaluate the Adhesion of TK-254RX in Healthy Volunteers.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Teikoku Seiyaku Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ClinSearch</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>SocraTec R&amp;D GmbH</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>SocraMetrics GmbH</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>CRM Biometrics GmbH</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Clinigen Clinical Supplies Management GmbH</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Teikoku Seiyaku Co., Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a multi center, multiple dose, open label trial to evaluate the adhesion of&#xD;
        TK-254RX in healthy volunteers. The primary purpose of this study is to evaluate the adhesion&#xD;
        of TK-254RX. Secondary purpose is to show TK-254RX is safe and to explore and compare&#xD;
        adhesion assessment methods.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Characterization of adhesion 5 minutes prior to removal by the adhesion assessment by site staff with EFTS marked by site staff</measure>
      <time_frame>5 minutes prior to removal,</time_frame>
      <description>Assessment/estimation by site staff with marked TK-254RX by site staff: A listing of individual values of percentage will be presented per time point and subject.&#xD;
  Descriptive statistics (Number, arithmetic mean, standard deviation, median, minimum and maximum) will be presented per time point for adhesion marker assessment by site staff with marked TK-254RX by site staff (percentage values).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Characterization of adhesion by visual estimation of subjects</measure>
      <time_frame>before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal</time_frame>
      <description>Visual Assessment by subjects with a 5 point-scale: A listing of classification (≥90%, ≥75% to &lt;90%, ≥50% to &lt;75%, &gt;0% to &lt;50%, completely detached) of adhesion per time point and subject will be given.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characterization of adhesion by the adhesion assessment by site staff with EFTS marked by subjects</measure>
      <time_frame>before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal</time_frame>
      <description>Assessment/estimation by site staff with marked TK-254RX by subject:&#xD;
  A listing of individual values of percentage will be presented per time point and subject.&#xD;
  Descriptive statistics (Number, arithmetic mean, standard deviation, median, minimum and maximum) will be presented per time point for adhesion marker assessment by site staff with marked TK-254RX by subject (percentage values).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of the adhesion assessments between subjects and study staff</measure>
      <time_frame>5minutes prior to removal</time_frame>
      <description>Three different adhesion assessments at 24hours as below will be performed. i. Visual assessment scale by subject ii. Assessment scale by site staff with marked TK-254RX by subject iii. Assessment scale by site staff with marked TK-254RX by site staff Comparison of i versus iii: the marked TK-254RX %-scale from iii are transformed into the 5-point scale (≥ 90%, ≥75% to &lt;90%, ≥50% to &lt;75%, &gt;0% to &lt;50%, completely detached); then the 5-point scale assessments from i and iii are compared via 5x5-cross tabulations and Spearman rank correlations.&#xD;
  Comparison of ii versus iii: the marked TK-254RX %-scale from ii and iii are transformed into the 5-point scale (≥ 90%, ≥75% to &lt;90%, ≥50% to &lt;75%, &gt;0% to &lt;50%, completely detached); then the 5-point scale assessments from ii and iii are compared via 5x5-cross tabulations and Spearman rank correlations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characterization of local tolerability during treatment</measure>
      <time_frame>within 5 minutes after removal of each patch</time_frame>
      <description>The skin will be visually checked and palpated for skin irritation or sensitization by trained personnel.&#xD;
  Local tolerability will be assessed by the Investigator according to FDA recommendations.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>TK-254RX applied to Lower Arm, Lower thigh or Ankle</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>For Group1, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects.&#xD;
  Day1: Lower Arm, Day2: Lower thigh, Day3: Ankle</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TK-254RX applied to Upper Arm, Upper thigh or Lower leg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>For Group2, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects.&#xD;
  Day1: Upper Arm, Day2: Upper thigh, Day3: Lower leg</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TK-254RX</intervention_name>
      <description>Two TK-254RX per day to predetermined application site</description>
      <arm_group_label>TK-254RX applied to Lower Arm, Lower thigh or Ankle</arm_group_label>
      <arm_group_label>TK-254RX applied to Upper Arm, Upper thigh or Lower leg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age: 18 to 64 years&#xD;
  &#xD;
            -  good state of health&#xD;
  &#xD;
            -  non-smoker or ex-smoker for at least 3 months&#xD;
  &#xD;
            -  written informed consent, after having been informed about benefits and potential&#xD;
               risks of the clinical trial, as well as details of the insurance taken out to cover&#xD;
               the subjects participating in the clinical trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          The following must not apply:&#xD;
  &#xD;
            -  any injury of body which may induce the restriction of body movement&#xD;
  &#xD;
            -  excessively hairy skin at application site&#xD;
  &#xD;
            -  current skin disorder or shaving hair at application site&#xD;
  &#xD;
            -  history of excessive sweating/hyperhidrosis inclusive of application site&#xD;
  &#xD;
            -  participation in a clinical study within 30 days before inclusion in the study or&#xD;
               concomitantly&#xD;
  &#xD;
            -  drug or alcohol abuse in the opinion of the investigator&#xD;
  &#xD;
            -  pregnant and lactating women&#xD;
  &#xD;
            -  women of child-bearing potential who do not agree to apply highly effective&#xD;
               contraceptive methods&#xD;
  &#xD;
            -  known hypersensitivity to active ingredient, its racemate or one of the excipients of&#xD;
               the TK-254RX&#xD;
  &#xD;
            -  existing cardiac and/or haematological diseases or pathological findings, which might&#xD;
               interfere with the safety or tolerability of the active ingredient&#xD;
  &#xD;
            -  existing hepatic and/or renal diseases or pathological findings, which might interfere&#xD;
               with the safety or tolerability of the active ingredient&#xD;
  &#xD;
            -  known liver or kidney insufficiency&#xD;
  &#xD;
            -  existing gastrointestinal diseases or pathological findings, which might interfere&#xD;
               with the safety or tolerability of the active ingredient&#xD;
  &#xD;
            -  history of relevant CNS and/or psychiatric disorders and/or currently treated CNS&#xD;
               and/or psychiatric disorders&#xD;
  &#xD;
            -  systolic blood pressure &lt; 90 or &gt; 139 mmHg&#xD;
  &#xD;
            -  diastolic blood pressure &lt; 60 or &gt; 89 mmHg&#xD;
  &#xD;
            -  pulse rate &lt; 50 bpm or &gt; 90 bpm&#xD;
  &#xD;
            -  subjects who use any impermissible medication&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kenichi Nishiyama</last_name>
      <role>Study Chair</role>
      <affiliation>Teikoku Seiyaku Co., Ltd.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hirofumi Fujiwara, Master</last_name>
      <phone>+81362649123</phone>
      <email>hirofumi-fujiwara@teiyaku.co.jp</email>
    </overall_contact>
    <location>
      <facility>
        <name>Medical Practice Ebert</name>
        <address>
          <city>Brühl</city>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Hans-Georg Predel, Prof. Dr.</last_name>
      </contact>
      <contact_backup>
        <last_name>Eduard Ebert, Dr.</last_name>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Medical practice Pabst</name>
        <address>
          <city>Fürstenfeldbruck</city>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Helmut Pabst, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Medical practice Gastl</name>
        <address>
          <city>Gilching</city>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Kai Gastl</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Medical Pracitice Schaale/Bücheler</name>
        <address>
          <city>Rheinbach</city>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</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>Tissue Adhesions</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042192
  org study id: TK-254RX-0106
  nct id: NCT06042192
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  This study is a multi center, multiple dose, open label trial to evaluate the adhesion of
        TK-254RX in healthy volunteers. The primary purpose of this study is to evaluate the adhesion
        of TK-254RX. Secondary purpose is to show TK-254RX is safe and to explore and compare
        adhesion assessment methods.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Characterization of adhesion 5 minutes prior to removal by the adhesion assessment by site staff with EFTS marked by site staff
  time frame: 5 minutes prior to removal,
  description: Assessment/estimation by site staff with marked TK-254RX by site staff: A listing of individual values of percentage will be presented per time point and subject.
  Descriptive statistics (Number, arithmetic mean, standard deviation, median, minimum and maximum) will be presented per time point for adhesion marker assessment by site staff with marked TK-254RX by site staff (percentage values).
  measure: Characterization of adhesion by visual estimation of subjects
  time frame: before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal
  description: Visual Assessment by subjects with a 5 point-scale: A listing of classification (≥90%, ≥75% to <90%, ≥50% to <75%, >0% to <50%, completely detached) of adhesion per time point and subject will be given.
  measure: Characterization of adhesion by the adhesion assessment by site staff with EFTS marked by subjects
  time frame: before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal
  description: Assessment/estimation by site staff with marked TK-254RX by subject:
  A listing of individual values of percentage will be presented per time point and subject.
  Descriptive statistics (Number, arithmetic mean, standard deviation, median, minimum and maximum) will be presented per time point for adhesion marker assessment by site staff with marked TK-254RX by subject (percentage values).
  measure: Comparison of the adhesion assessments between subjects and study staff
  time frame: 5minutes prior to removal
  description: Three different adhesion assessments at 24hours as below will be performed. i. Visual assessment scale by subject ii. Assessment scale by site staff with marked TK-254RX by subject iii. Assessment scale by site staff with marked TK-254RX by site staff Comparison of i versus iii: the marked TK-254RX %-scale from iii are transformed into the 5-point scale (≥ 90%, ≥75% to <90%, ≥50% to <75%, >0% to <50%, completely detached); then the 5-point scale assessments from i and iii are compared via 5x5-cross tabulations and Spearman rank correlations.
  Comparison of ii versus iii: the marked TK-254RX %-scale from ii and iii are transformed into the 5-point scale (≥ 90%, ≥75% to <90%, ≥50% to <75%, >0% to <50%, completely detached); then the 5-point scale assessments from ii and iii are compared via 5x5-cross tabulations and Spearman rank correlations.
  measure: Characterization of local tolerability during treatment
  time frame: within 5 minutes after removal of each patch
  description: The skin will be visually checked and palpated for skin irritation or sensitization by trained personnel.
  Local tolerability will be assessed by the Investigator according to FDA recommendations.
  arm group label: TK-254RX applied to Lower Arm, Lower thigh or Ankle
  arm group type: Experimental
  description: For Group1, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects.
  Day1: Lower Arm, Day2: Lower thigh, Day3: Ankle
  arm group label: TK-254RX applied to Upper Arm, Upper thigh or Lower leg
  arm group type: Experimental
  description: For Group2, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects.
  Day1: Upper Arm, Day2: Upper thigh, Day3: Lower leg
  intervention type: Drug
  intervention name: TK-254RX
  description: Two TK-254RX per day to predetermined application site
  arm group label: TK-254RX applied to Lower Arm, Lower thigh or Ankle
  arm group label: TK-254RX applied to Upper Arm, Upper thigh or Lower leg
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kenichi Nishiyama
  role: Study Chair
  affiliation: Teikoku Seiyaku Co., Ltd.
  last name: Hirofumi Fujiwara, Master
  phone: +81362649123
  email: hirofumi-fujiwara@teiyaku.co.jp
  facility: 
  contact: 
  contact backup: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Tissue Adhesions
  sharing ipd: No