<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/NCT01676090</url>
  </required_header>
  <id_info>
    <org_study_id>A-92-52800-020</org_study_id>
    <nct_id>NCT01676090</nct_id>
  </id_info>
  <brief_title>IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish Population</brief_title>
  <acronym>EDISON</acronym>
  <official_title>An Epidemiologic, Descriptive and Cross-sectional Study of the IGF-1, IGFBP-3 and ALS Normative Ranges in a Healthy Paediatric Spanish Population, Divided Into Chronological Age, Sex and Pubertal Stage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ipsen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ipsen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like&#xD;
      growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex&#xD;
      and pubertal stage of a healthy paediatric Spanish population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Participant enrolment was lower than expected&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>IGF-1 levels according to age, sex and pubertal stage in healthy paediatric volunteers</measure>
    <time_frame>At the time of participant's single study visit (day 1)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>IGFBP-3 levels according to age, sex and pubertal stage in healthy paediatric volunteers</measure>
    <time_frame>At the time of participant's single study visit (day 1)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALS levels according to age, sex and pubertal stage in healthy paediatric volunteers</measure>
    <time_frame>At the time of participant's single study visit (day 1)</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">304</enrollment>
  <condition>IGF-1 Deficiency</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy paediatric Spanish population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children of either sex of Caucasian parents&#xD;
&#xD;
          -  Age: newborns up to and including 18 years of age&#xD;
&#xD;
          -  Length/height, weight and body mass index (BMI) within the mean +/- 2SD (Standard&#xD;
             Deviation) and in accordance with the growth charts of the 2010 Spanish&#xD;
             cross-sectional growth study (Carrascosa Lezcano et al 2010)&#xD;
&#xD;
          -  Signed consent by at least one parent or legal guardian (if subject is ≤18 years) and&#xD;
             by subject if ≥12 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Early or advanced puberty (pubertal signs: between 8 and 9 years old in girls, and&#xD;
             between 9 and 10 years old in boys), or delayed puberty (no puberty onset in ≥ 13&#xD;
             year-old girls, and in ≥ 14 year-old boys)&#xD;
&#xD;
          -  Chronic diseases including, but not limited to, endocrinologic diseases, chromosomal&#xD;
             diseases, chronic diseases of renal, hepatic and/or cardiac aetiology, and tumour&#xD;
             processes&#xD;
&#xD;
          -  An acute disease during the last two weeks prior to recruitment&#xD;
&#xD;
          -  Any clinically significant out-of-range lab value&#xD;
&#xD;
          -  Healthy paediatric volunteers who are under medical treatment (contraception&#xD;
             permitted)&#xD;
&#xD;
          -  A family history of short stature (either parent &lt; P3)&#xD;
&#xD;
          -  Children born small for gestational age (birth weight, length, or head circumference &lt;&#xD;
             P10)&#xD;
&#xD;
          -  Adopted children or conceived through in vitro fertilization ( IVF )&#xD;
&#xD;
          -  Subjects who are unwilling or unable in the opinion of the investigator or sponsor to&#xD;
             undergo all the study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ipsen Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Ipsen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fundación Sant Joan de Deu</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d´Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cruces</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infantil Universitario Niño Jesús</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago de Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Nuestra Señora de Valme</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01676090
org study id: A-92-52800-020
nct id: NCT01676090
lead sponsor: 
has dmc: No
To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like
      growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex
      and pubertal stage of a healthy paediatric Spanish population.
observational model: Other
time perspective: Cross-Sectional
measure: IGF-1 levels according to age, sex and pubertal stage in healthy paediatric volunteers
time frame: At the time of participant's single study visit (day 1)
measure: IGFBP-3 levels according to age, sex and pubertal stage in healthy paediatric volunteers
time frame: At the time of participant's single study visit (day 1)
measure: ALS levels according to age, sex and pubertal stage in healthy paediatric volunteers
time frame: At the time of participant's single study visit (day 1)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ipsen Medical Director
role: Study Director
affiliation: Ipsen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor