<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/NCT04484428</url>
  </required_header>
  <id_info>
    <org_study_id>K-285-201</org_study_id>
    <nct_id>NCT04484428</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity</brief_title>
  <official_title>A Phase II, Randomized, Double-blind, Active Comparator, Parallel Group Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kowa Research Institute, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kowa Research Institute, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study to evaluate the efficacy and safety of K-285 compared with menthol&#xD;
      gel for the treatment of delayed onset muscle soreness (DOMS) in the lower extremity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Internal business decision&#xD;
  </why_stopped>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Actual">March 19, 2021</completion_date>
  <primary_completion_date type="Actual">March 19, 2021</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The sum of pain intensity difference (SPID) between 0 to 24 hours (SPID 0-24) for study leg while standing</measure>
    <time_frame>0 to 24 hours after the first gel application</time_frame>
    <description>Using a 0-100 point electronic visual analog scale (eVAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SPID 0-24 for study leg at rest</measure>
    <time_frame>0 to 24 hours after the first gel application</time_frame>
    <description>Using a 0-100 point eVAS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPID 0-12 for study leg while standing and at rest</measure>
    <time_frame>0 to 12 hours after the first gel application</time_frame>
    <description>Using a 0-100 point eVAS scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPID 0-48 for study leg while standing and at rest</measure>
    <time_frame>0 to 48 hours after the first gel application</time_frame>
    <description>Using a 0-100 point eVAS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPID 0-72 for study leg while standing and at rest</measure>
    <time_frame>0 to 72 hours after the first gel application</time_frame>
    <description>Using a 0-100 point eVAS scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>Treatment Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>K-285</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Arm B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Menthol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>K-285</intervention_name>
    <description>88 subjects are to be assigned to 1 week dosing, four times a day (QID) (Period 1), and 32 are to be assigned to 3 weeks dosing (Period 1 and Period 2) with 16 subjects each in the two times a day (BID) and QID dosing regimens.</description>
    <arm_group_label>Treatment Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Menthol</intervention_name>
    <description>88 subjects are to be assigned to 1 week dosing, four times a day (QID) (Period 1), and 32 are to be assigned to 3 weeks dosing (Period 1 and Period 2) with 16 subjects each in the two times a day (BID) and QID dosing regimens.</description>
    <arm_group_label>Treatment Arm B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must provide informed consent before any study-specific evaluation is&#xD;
             performed.&#xD;
&#xD;
          -  Subject is male and female aged 18 to 35 years, inclusive.&#xD;
&#xD;
          -  Subject has a body mass index of 18 to 32 kg/m2, inclusive.&#xD;
&#xD;
          -  Subject meets all inclusion criteria outlined in the Clinical Study Protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a job (e.g., movers, construction workers) that requires regular lifting&#xD;
             or involvement of the lower extremities.&#xD;
&#xD;
          -  Subject has restless leg syndrome, a chronic pain condition, a history of intermittent&#xD;
             claudication, or has taken any medication (e.g., analgesic medication, sleep&#xD;
             medication, muscle relaxant, anticonvulsant, or antidepressant) in the last 6 months&#xD;
             to treat a chronic pain condition, or has another painful physical condition in a&#xD;
             lower extremity that, in the opinion of the investigator, may confound study&#xD;
             assessments.&#xD;
&#xD;
          -  Subject has received oral or topical analgesic medications within 14 days before the&#xD;
             Screening Visit.&#xD;
&#xD;
          -  Subject meet any other exclusion criteria outlined in the Clinical Study Protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lotus Clinical Research, LLC</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <disposition_first_submitted>March 11, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>March 11, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 16, 2022</disposition_first_posted>
  <last_update_submitted>March 11, 2022</last_update_submitted>
  <last_update_submitted_qc>March 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</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>Myalgia</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menthol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04484428
org study id: K-285-201
nct id: NCT04484428
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study to evaluate the efficacy and safety of K-285 compared with menthol
      gel for the treatment of delayed onset muscle soreness (DOMS) in the lower extremity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: The sum of pain intensity difference (SPID) between 0 to 24 hours (SPID 0-24) for study leg while standing
time frame: 0 to 24 hours after the first gel application
description: Using a 0-100 point electronic visual analog scale (eVAS)
measure: SPID 0-24 for study leg at rest
time frame: 0 to 24 hours after the first gel application
description: Using a 0-100 point eVAS scale
measure: SPID 0-12 for study leg while standing and at rest
time frame: 0 to 12 hours after the first gel application
description: Using a 0-100 point eVAS scale.
measure: SPID 0-48 for study leg while standing and at rest
time frame: 0 to 48 hours after the first gel application
description: Using a 0-100 point eVAS scale
measure: SPID 0-72 for study leg while standing and at rest
time frame: 0 to 72 hours after the first gel application
description: Using a 0-100 point eVAS scale
arm group label: Treatment Arm A
arm group type: Experimental
description: K-285
arm group label: Treatment Arm B
arm group type: Active Comparator
description: Menthol
intervention type: Drug
intervention name: K-285
description: 88 subjects are to be assigned to 1 week dosing, four times a day (QID) (Period 1), and 32 are to be assigned to 3 weeks dosing (Period 1 and Period 2) with 16 subjects each in the two times a day (BID) and QID dosing regimens.
arm group label: Treatment Arm A
intervention type: Drug
intervention name: Menthol
description: 88 subjects are to be assigned to 1 week dosing, four times a day (QID) (Period 1), and 32 are to be assigned to 3 weeks dosing (Period 1 and Period 2) with 16 subjects each in the two times a day (BID) and QID dosing regimens.
arm group label: Treatment Arm B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Myalgia
mesh term: Acute Pain
mesh term: Menthol