<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/NCT03827590</url>
  </required_header>
  <id_info>
    <org_study_id>HLIM(SA16002)</org_study_id>
    <nct_id>NCT03827590</nct_id>
  </id_info>
  <brief_title>Clinical Trials to Assess the Efficacy and Safety of HLIM</brief_title>
  <official_title>Phase III Clinical Trials to Assess the Efficacy and Safety of HLIM for Symptomatic Relief of Cough and Sputum in Patients With Acute Upper Respiratory Tract Infection or Acute Bronchitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SamA Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SamA Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of HLIM&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Anticipated">October 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2019</primary_completion_date>
  <phase>Phase 3</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>Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo</measure>
    <time_frame>5 days</time_frame>
    <description>0(absent) ~ 4(very severe), Total Score: 0~20</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group</measure>
    <time_frame>5 days</time_frame>
    <description>0(absent) ~ 4(very severe), Total Score: 0~20</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">487</enrollment>
  <condition>Acute Upper Respiratory Tract Infection</condition>
  <condition>Acute Bronchitis</condition>
  <arm_group>
    <arm_group_label>HLIM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HLIM+SA160021 Placebo+SA160022 Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SA160021</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>HLIM Placebo+SA160021+SA160022 Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SA160022</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>HLIM Placebo+SA160021 Placebo+SA160022</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>HLIM Placebo+SA160021 Placebo+SA160022 Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Test</intervention_name>
    <description>three times a day for five days</description>
    <arm_group_label>HLIM</arm_group_label>
    <other_name>HLIM+SA160021 Placebo+SA160022 Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active Comparator Control 1</intervention_name>
    <description>three times a day for five days</description>
    <arm_group_label>SA160021</arm_group_label>
    <other_name>HLIM Placebo+SA160021+SA160022 Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Active Comparator Control 2</intervention_name>
    <description>three times a day for five days</description>
    <arm_group_label>SA160022</arm_group_label>
    <other_name>HLIM Placebo+SA160021 Placebo+SA160022</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>three times a day for five days</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>HLIM Placebo+SA160021 Placebo+SA160022 Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 2 and 75&#xD;
&#xD;
          -  Weight more than 11.5 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a history of hypersensitivity to IP ingredients&#xD;
&#xD;
          -  Hypertension or Diabetes&#xD;
&#xD;
          -  Smoking more than 20 pack-years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Guro-gu</state>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jaejung Shim, M.D., Ph.D</last_name>
      <phone>+82-2-2626-1114</phone>
      <email>jaejshim@kumc.or.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</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>Infections</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Bronchitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03827590
org study id: HLIM(SA16002)
nct id: NCT03827590
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to assess the efficacy and safety of HLIM
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo
time frame: 5 days
description: 0(absent) ~ 4(very severe), Total Score: 0~20
measure: Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group
time frame: 5 days
description: 0(absent) ~ 4(very severe), Total Score: 0~20
arm group label: HLIM
arm group type: Experimental
description: HLIM+SA160021 Placebo+SA160022 Placebo
arm group label: SA160021
arm group type: Active Comparator
description: HLIM Placebo+SA160021+SA160022 Placebo
arm group label: SA160022
arm group type: Active Comparator
description: HLIM Placebo+SA160021 Placebo+SA160022
arm group label: Placebo
arm group type: Placebo Comparator
description: HLIM Placebo+SA160021 Placebo+SA160022 Placebo
intervention type: Drug
intervention name: Test
description: three times a day for five days
arm group label: HLIM
other name: HLIM+SA160021 Placebo+SA160022 Placebo
intervention type: Drug
intervention name: Active Comparator Control 1
description: three times a day for five days
arm group label: SA160021
other name: HLIM Placebo+SA160021+SA160022 Placebo
intervention type: Drug
intervention name: Active Comparator Control 2
description: three times a day for five days
arm group label: SA160022
other name: HLIM Placebo+SA160021 Placebo+SA160022
intervention type: Drug
intervention name: Placebo
description: three times a day for five days
arm group label: Placebo
other name: HLIM Placebo+SA160021 Placebo+SA160022 Placebo
criteria: 
gender: All
minimum age: 2 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Infections
mesh term: Respiratory Tract Infections
mesh term: Bronchitis
sharing ipd: Undecided