<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/NCT01731028</url>
  </required_header>
  <id_info>
    <org_study_id>000091</org_study_id>
    <nct_id>NCT01731028</nct_id>
  </id_info>
  <brief_title>Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®</brief_title>
  <official_title>Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the long-term treatment with Zomacton® for&#xD;
      pituitary short stature in children with insufficient growth hormone production and/or short&#xD;
      stature caused by Turner's syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Change of local requirements&#xD;
  </why_stopped>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of Zomacton® treatment measured by the increase in body height per annuum</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of Zomacton® treatment measured by the increase in body weight per annuum</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Zomacton® and the application device measured by local adverse reactions to the application device</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Growth Hormone Deficiency</condition>
  <arm_group>
    <arm_group_label>Somatropin</arm_group_label>
    <description>Children with growth hormone deficiency treated with somatropin as Zomacton® according to the marketing authorization</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Somatropin</intervention_name>
    <description>Somatropin powder and solvent for solution for injection</description>
    <arm_group_label>Somatropin</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with inadequate secretion of growth-hormone; growth retardation due to Turner's&#xD;
        syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  therapeutic need according to the approved specific products characteristics (SPC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication according to the SPC&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Development Support</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>January 31, 2013</last_update_submitted>
  <last_update_submitted_qc>January 31, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2013</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, Pituitary</mesh_term>
    <mesh_term>Endocrine System Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT01731028
org study id: 000091
nct id: NCT01731028
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the long-term treatment with Zomacton® for
      pituitary short stature in children with insufficient growth hormone production and/or short
      stature caused by Turner's syndrome.
observational model: Cohort
time perspective: Prospective
measure: Efficacy of Zomacton® treatment measured by the increase in body height per annuum
time frame: 5 years
measure: Efficacy of Zomacton® treatment measured by the increase in body weight per annuum
time frame: 5 years
measure: Safety of Zomacton® and the application device measured by local adverse reactions to the application device
time frame: 5 years
arm group label: Somatropin
description: Children with growth hormone deficiency treated with somatropin as Zomacton® according to the marketing authorization
intervention type: Drug
intervention name: Somatropin
description: Somatropin powder and solvent for solution for injection
arm group label: Somatropin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
last name: Clinical Development Support
role: Study Director
affiliation: Ferring Pharmaceuticals
responsible party type: Sponsor
mesh term: Dwarfism, Pituitary
mesh term: Endocrine System Diseases