<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/NCT01697644</url>
  </required_header>
  <id_info>
    <org_study_id>GHRETARD/NL/21</org_study_id>
    <nct_id>NCT01697644</nct_id>
  </id_info>
  <brief_title>Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation</brief_title>
  <official_title>Growth Hormone Treatment of Children After Intrauterine Growth Retardation</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 and compare the&#xD;
      efficacy and safety of two dose levels of somatropin over a long period (till final height is&#xD;
      reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial)&#xD;
      and GHRETARD/BPD/20/NL (a 2-year extension trial).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 1990</start_date>
  <completion_date type="Actual">May 2005</completion_date>
  <primary_completion_date type="Actual">May 2005</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Linear growth (height during childhood)</measure>
  </primary_outcome>
  <primary_outcome>
    <measure>Final height</measure>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone maturation</measure>
  </primary_outcome>
  <primary_outcome>
    <measure>Pubertal development</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Foetal Growth Problem</condition>
  <condition>Small for Gestational Age</condition>
  <arm_group>
    <arm_group_label>Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>somatropin</intervention_name>
    <description>3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily</description>
    <arm_group_label>Low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>somatropin</intervention_name>
    <description>3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily</description>
    <arm_group_label>High dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completion of the GHRETARD/BPD/20/NL trial&#xD;
&#xD;
          -  Written informed consent from child and/or parents/guardians before continuation in&#xD;
             the extension trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry B. (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>Rotterdam</city>
        <zip>3015 CN</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 GJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <results_reference>
    <citation>Boonstra V, van Pareren Y, Mulder P, Hokken-Koelega A. Puberty in growth hormone-treated children born small for gestational age (SGA). J Clin Endocrinol Metab. 2003 Dec;88(12):5753-8. doi: 10.1210/jc.2003-030512.</citation>
    <PMID>14671164</PMID>
  </results_reference>
  <results_reference>
    <citation>Sas T, de Waal W, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Growth hormone treatment in children with short stature born small for gestational age: 5-year results of a randomized, double-blind, dose-response trial. J Clin Endocrinol Metab. 1999 Sep;84(9):3064-70. doi: 10.1210/jcem.84.9.5942.</citation>
    <PMID>10487666</PMID>
  </results_reference>
  <results_reference>
    <citation>Sas T, Mulder P, Hokken-Koelega A. Body composition, blood pressure, and lipid metabolism before and during long-term growth hormone (GH) treatment in children with short stature born small for gestational age either with or without GH deficiency. J Clin Endocrinol Metab. 2000 Oct;85(10):3786-92. doi: 10.1210/jcem.85.10.6917.</citation>
    <PMID>11061539</PMID>
  </results_reference>
  <results_reference>
    <citation>Sas TC, Gerver WJ, De Bruin R, Mulder PG, Cole TJ, De Waal W, Hokken-Koelega AC. Body proportions during 6 years of GH treatment in children with short stature born small for gestational age participating in a randomised, double-blind, dose-response trial. Clin Endocrinol (Oxf). 2000 Dec;53(6):675-81. doi: 10.1046/j.1365-2265.2000.01155.x.</citation>
    <PMID>11155088</PMID>
  </results_reference>
  <results_reference>
    <citation>Sas T, Mulder P, Aanstoot HJ, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Carbohydrate metabolism during long-term growth hormone treatment in children with short stature born small for gestational age. Clin Endocrinol (Oxf). 2001 Feb;54(2):243-51. doi: 10.1046/j.1365-2265.2001.01178.x.</citation>
    <PMID>11207640</PMID>
  </results_reference>
  <results_reference>
    <citation>Van Pareren Y, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Adult height after long-term, continuous growth hormone (GH) treatment in short children born small for gestational age: results of a randomized, double-blind, dose-response GH trial. J Clin Endocrinol Metab. 2003 Aug;88(8):3584-90. doi: 10.1210/jc.2002-021172.</citation>
    <PMID>12915640</PMID>
  </results_reference>
  <results_reference>
    <citation>van Pareren Y, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Effect of discontinuation of growth hormone treatment on risk factors for cardiovascular disease in adolescents born small for gestational age. J Clin Endocrinol Metab. 2003 Jan;88(1):347-53. doi: 10.1210/jc.2002-020458.</citation>
    <PMID>12519875</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 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/NCT01697644
org study id: GHRETARD/NL/21
nct id: NCT01697644
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of this trial is to assess and compare the
      efficacy and safety of two dose levels of somatropin over a long period (till final height is
      reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial)
      and GHRETARD/BPD/20/NL (a 2-year extension trial).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Linear growth (height during childhood)
measure: Final height
measure: Bone maturation
measure: Pubertal development
measure: Adverse events
arm group label: Low dose
arm group type: Experimental
arm group label: High dose
arm group type: Experimental
intervention type: Drug
intervention name: somatropin
description: 3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
arm group label: Low dose
intervention type: Drug
intervention name: somatropin
description: 3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
arm group label: High dose
criteria: 
gender: All
minimum age: 3 Years
maximum age: 11 Years
healthy volunteers: No
last name: Global Clinical Registry B. (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
facility: 
country: Netherlands
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
citation: Boonstra V, van Pareren Y, Mulder P, Hokken-Koelega A. Puberty in growth hormone-treated children born small for gestational age (SGA). J Clin Endocrinol Metab. 2003 Dec;88(12):5753-8. doi: 10.1210/jc.2003-030512.
PMID: 14671164
citation: Sas T, de Waal W, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Growth hormone treatment in children with short stature born small for gestational age: 5-year results of a randomized, double-blind, dose-response trial. J Clin Endocrinol Metab. 1999 Sep;84(9):3064-70. doi: 10.1210/jcem.84.9.5942.
PMID: 10487666
citation: Sas T, Mulder P, Hokken-Koelega A. Body composition, blood pressure, and lipid metabolism before and during long-term growth hormone (GH) treatment in children with short stature born small for gestational age either with or without GH deficiency. J Clin Endocrinol Metab. 2000 Oct;85(10):3786-92. doi: 10.1210/jcem.85.10.6917.
PMID: 11061539
citation: Sas TC, Gerver WJ, De Bruin R, Mulder PG, Cole TJ, De Waal W, Hokken-Koelega AC. Body proportions during 6 years of GH treatment in children with short stature born small for gestational age participating in a randomised, double-blind, dose-response trial. Clin Endocrinol (Oxf). 2000 Dec;53(6):675-81. doi: 10.1046/j.1365-2265.2000.01155.x.
PMID: 11155088
citation: Sas T, Mulder P, Aanstoot HJ, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Carbohydrate metabolism during long-term growth hormone treatment in children with short stature born small for gestational age. Clin Endocrinol (Oxf). 2001 Feb;54(2):243-51. doi: 10.1046/j.1365-2265.2001.01178.x.
PMID: 11207640
citation: Van Pareren Y, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Adult height after long-term, continuous growth hormone (GH) treatment in short children born small for gestational age: results of a randomized, double-blind, dose-response GH trial. J Clin Endocrinol Metab. 2003 Aug;88(8):3584-90. doi: 10.1210/jc.2002-021172.
PMID: 12915640
citation: van Pareren Y, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Effect of discontinuation of growth hormone treatment on risk factors for cardiovascular disease in adolescents born small for gestational age. J Clin Endocrinol Metab. 2003 Jan;88(1):347-53. doi: 10.1210/jc.2002-020458.
PMID: 12519875
responsible party type: Sponsor
mesh term: Fetal Growth Retardation