<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/NCT03015909</url>
  </required_header>
  <id_info>
    <org_study_id>LG-HGCL008</org_study_id>
    <nct_id>NCT03015909</nct_id>
  </id_info>
  <brief_title>Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.</brief_title>
  <official_title>A Multi-center, Open, Single-arm, Switch-over, Prospective, Phase IV Study to Assess the Ease of Use, Preference, and Safety After 8 Weeks Subcutaneous Administration of EutropinPen Inj. in Patients Pretreated With Recombinant Human Growth Hormone by Reusable Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LG Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LG Life Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the ease of use, preference, and safety after 8 weeks&#xD;
      subcutaneous administration of EutropinPen Inj. in patients pretreated with recombinant human&#xD;
      growth hormone by reusable device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2016</start_date>
  <completion_date type="Actual">December 21, 2017</completion_date>
  <primary_completion_date type="Actual">December 21, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire.</measure>
    <time_frame>Day 57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire.</measure>
    <time_frame>Day 57</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Benefits of EutropinPen inj. assessed by a questionnaire</measure>
    <time_frame>Day 57</time_frame>
    <description>Ease of use&#xD;
Unit&#xD;
High dose packing&#xD;
Grip&#xD;
Design&#xD;
Less pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear assessed by a questionnaire</measure>
    <time_frame>Screening, Day 57</time_frame>
    <description>Ask of fearness how the child feels about the needle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire</measure>
    <time_frame>Screening, Day 57</time_frame>
    <description>Ask ease of use at each injection step (1~5 pts)&#xD;
Preparation time for injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment compliance of EutropinPen Inj. (%)</measure>
    <time_frame>Day 57</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Short Stature, Idiopathic</condition>
  <condition>Infant, Small for Gestational Age</condition>
  <condition>Growth Hormone Deficiency</condition>
  <condition>Chronic Renal Failure</condition>
  <condition>Turner Syndrome</condition>
  <arm_group>
    <arm_group_label>Eutropin pen inj.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Somatropin</intervention_name>
    <arm_group_label>Eutropin pen inj.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who has been using reusable device growth hormone injection in recent 3&#xD;
             months at least for 6 weeks&#xD;
&#xD;
          -  Subjects who meets the indication of EutropinPen inj.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who has diseases below on screening visit&#xD;
&#xD;
               -  Diabetes&#xD;
&#xD;
               -  Malignant tumor&#xD;
&#xD;
               -  Epiphyseal closure&#xD;
&#xD;
               -  Chronic kidney disease (recieved kidney transplantation)&#xD;
&#xD;
               -  Acute respitory failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ajou university hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeong-gi</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>January 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 1, 2019</last_update_submitted>
  <last_update_submitted_qc>January 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 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>Dwarfism</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Turner Syndrome</mesh_term>
    <mesh_term>Gonadal Dysgenesis</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/NCT03015909
org study id: LG-HGCL008
nct id: NCT03015909
lead sponsor: 
has dmc: No
The purpose of this study is to assess the ease of use, preference, and safety after 8 weeks
      subcutaneous administration of EutropinPen Inj. in patients pretreated with recombinant human
      growth hormone by reusable device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
time frame: Day 57
measure: Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
time frame: Day 57
measure: Benefits of EutropinPen inj. assessed by a questionnaire
time frame: Day 57
description: Ease of use
Unit
High dose packing
Grip
Design
Less pain
measure: Fear assessed by a questionnaire
time frame: Screening, Day 57
description: Ask of fearness how the child feels about the needle
measure: Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire
time frame: Screening, Day 57
description: Ask ease of use at each injection step (1~5 pts)
Preparation time for injection
measure: Treatment compliance of EutropinPen Inj. (%)
time frame: Day 57
arm group label: Eutropin pen inj.
arm group type: Other
intervention type: Drug
intervention name: Somatropin
arm group label: Eutropin pen inj.
criteria: 
gender: All
minimum age: 4 Years
maximum age: 15 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dwarfism
mesh term: Kidney Failure, Chronic
mesh term: Turner Syndrome
mesh term: Gonadal Dysgenesis
sharing ipd: Undecided