<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/NCT01734447</url>
  </required_header>
  <id_info>
    <org_study_id>GHRETARD/F/2/F</org_study_id>
    <nct_id>NCT01734447</nct_id>
  </id_info>
  <brief_title>Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation</brief_title>
  <official_title>Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term&#xD;
      growth hormone treatment in growth-retarded children with intrauterine growth retardation&#xD;
      (IUGR) enrolled in trial GHRETARD/F/1/F.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2000</start_date>
  <completion_date type="Actual">April 30, 2003</completion_date>
  <primary_completion_date type="Actual">April 30, 2003</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pubertal development, assessed according to Tanner method</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height velocity</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final height</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse Events</measure>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Foetal Growth Problem</condition>
  <condition>Small for Gestational Age</condition>
  <arm_group>
    <arm_group_label>1.2, continuous treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>1.2, non-continuous treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>2.4, non-continuous treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>somatropin</intervention_name>
    <description>1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months</description>
    <arm_group_label>1.2, continuous treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>somatropin</intervention_name>
    <description>1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)</description>
    <arm_group_label>1.2, non-continuous treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>somatropin</intervention_name>
    <description>2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)</description>
    <arm_group_label>2.4, non-continuous treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients born with IUGR enrolled in trial GHRETARD/F/1/F&#xD;
&#xD;
          -  Bone age below 14 years in boys and 12 years in girls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bone age above 14 years in boys and 12 years in girls&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry (GCR, 1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>February 27, 2017</last_update_submitted>
  <last_update_submitted_qc>February 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2017</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>Fetal Growth Retardation</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/NCT01734447
org study id: GHRETARD/F/2/F
nct id: NCT01734447
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term
      growth hormone treatment in growth-retarded children with intrauterine growth retardation
      (IUGR) enrolled in trial GHRETARD/F/1/F.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion
measure: Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray
measure: Pubertal development, assessed according to Tanner method
measure: Height velocity
measure: Final height
measure: Number of Adverse Events
arm group label: 1.2, continuous treatment
arm group type: Experimental
arm group label: 1.2, non-continuous treatment
arm group type: Experimental
arm group label: 2.4, non-continuous treatment
arm group type: Experimental
intervention type: Drug
intervention name: somatropin
description: 1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months
arm group label: 1.2, continuous treatment
intervention type: Drug
intervention name: somatropin
description: 1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
arm group label: 1.2, non-continuous treatment
intervention type: Drug
intervention name: somatropin
description: 2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
arm group label: 2.4, non-continuous treatment
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: France
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Fetal Growth Retardation