<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/NCT02208076</url>
  </required_header>
  <id_info>
    <org_study_id>EMR200104-537</org_study_id>
    <nct_id>NCT02208076</nct_id>
  </id_info>
  <brief_title>To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Columbia</brief_title>
  <acronym>ECOS COL</acronym>
  <official_title>Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using &quot;Easypod™&quot; Electromechanical Device for Growth Hormone Treatment in Columbia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck KGaA, Darmstadt, Germany</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck S.A. Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Merck KGaA, Darmstadt, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Columbian, Multicentre, Observational Study to evaluate Adherence and Long Term&#xD;
      Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth&#xD;
      hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via&#xD;
      easypod™.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects&#xD;
      will provide their Informed Consent/assent to upload their data for population-based analyses&#xD;
      and, ultimately, clinical outcomes. Adherence data will be primarily derived from the&#xD;
      easypod™ device combined with physician data entry of outcome measures. Data will be&#xD;
      collected both retrospectively and prospectively. This will allow the establishment of&#xD;
      adherence profiles and explore the hypothesis that patient adherence support programs improve&#xD;
      adherence and subsequent clinical outcomes. Collected data will be also analyzed in a&#xD;
      multinational pooled analysis of comparable national studies.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      • To assess the level of adherence of subjects receiving SAIZEN® via easypod™&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®&#xD;
           via easypod™&#xD;
&#xD;
        -  To identify adherence subject profiling&#xD;
&#xD;
        -  To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above,&#xD;
           below or within normal ranges)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2014</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean percent of daily recorded adherence</measure>
    <time_frame>At least 6 months and up to 5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™</measure>
    <time_frame>At least 6 months and up to 5 years</time_frame>
    <description>Correlation of adherence and growth outcome (change in: height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height-standard deviation score(height SDS)) after each year of SAIZEN® treatment with easypod™</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment</measure>
    <time_frame>At least 6 months and up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges)</measure>
    <time_frame>At least 6 months and up to 5 years</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">44</enrollment>
  <condition>Growth Disorders</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>easypod™</intervention_name>
    <description>Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™</description>
    <other_name>Saizen</other_name>
    <other_name>Somatropin</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the&#xD;
        easypod™ electromechanical device.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Administered growth hormone via the easypod™ electromechanical device according to&#xD;
             Summary of Product Characteristic (SmPC)&#xD;
&#xD;
          -  Over the age of &gt;2 years&#xD;
&#xD;
          -  Under &lt;18 years of age, or over 18 without fusion of growth plates&#xD;
&#xD;
          -  Parent's or guardian's written informed consent, given before entering data into the&#xD;
             observational study, with the understanding that the subject or parent/guardian may&#xD;
             withdraw consent at any time without prejudice to future medical care. If the child is&#xD;
             old enough to read and write, a separate assent form will be given as defined in the&#xD;
             appropriate jurisdiction of each country&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects taking growth hormone in whom growth plates have fused (i.e. for taking&#xD;
             growth hormone for it's metabolic effects)&#xD;
&#xD;
          -  Contra-indications to SAIZEN® as defined in the SmPC&#xD;
&#xD;
          -  Use of an investigational drug or participation in another interventional clinical&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck S.A., Colombia, an affiliate of Merck KGaA, Darmstadt, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For Recruiting Locations in Colombia</name>
      <address>
        <city>Please Contact The Merck KGaA Communication Center</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <results_reference>
    <citation>Koledova, E. et al. (2017) Analysis of results from the global, 5-year Easypod™ Connect Observational Study (ECOS) study in children with growth disorders. 10th International Meeting for Pediatric Endocrinology; 2017 Sep 14-17; Washington, DC.</citation>
  </results_reference>
  <results_reference>
    <citation>Wit, JM. et al. (2017) Effect of adherence on the 2-year growth response to growth hormone treatment in prepubertal children with idiopathic isolated growth hormone deficiency participating in the EasypodTM Connect Observational Study (ECOS). 10th International Meeting of Paediatric Endocrinology; 2017 Sep 14-17; Washington, DC.</citation>
  </results_reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>July 22, 2013</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>December 22, 2017</last_update_submitted>
  <last_update_submitted_qc>December 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Growth disorders</keyword>
  <keyword>Saizen</keyword>
  <keyword>Easypod</keyword>
  <keyword>Growth hormone</keyword>
  <keyword>Pediatric subject</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Growth Disorders</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/NCT02208076
org study id: EMR200104-537
nct id: NCT02208076
lead sponsor: 
collaborator: 
has dmc: No
This is a Columbian, Multicentre, Observational Study to evaluate Adherence and Long Term
      Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth
      hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via
      easypod™.
Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects
      will provide their Informed Consent/assent to upload their data for population-based analyses
      and, ultimately, clinical outcomes. Adherence data will be primarily derived from the
      easypod™ device combined with physician data entry of outcome measures. Data will be
      collected both retrospectively and prospectively. This will allow the establishment of
      adherence profiles and explore the hypothesis that patient adherence support programs improve
      adherence and subsequent clinical outcomes. Collected data will be also analyzed in a
      multinational pooled analysis of comparable national studies.

      Primary Objective:

      • To assess the level of adherence of subjects receiving SAIZEN® via easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To identify adherence subject profiling

        -  To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above,
           below or within normal ranges)
observational model: Cohort
time perspective: Other
measure: Mean percent of daily recorded adherence
time frame: At least 6 months and up to 5 years
measure: Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™
time frame: At least 6 months and up to 5 years
description: Correlation of adherence and growth outcome (change in: height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height-standard deviation score(height SDS)) after each year of SAIZEN® treatment with easypod™
measure: Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment
time frame: At least 6 months and up to 5 years
measure: Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges)
time frame: At least 6 months and up to 5 years
intervention type: Device
intervention name: easypod™
description: Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™
other name: Saizen
other name: Somatropin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck S.A., Colombia, an affiliate of Merck KGaA, Darmstadt, Germany
facility: 
country: Colombia
citation: Koledova, E. et al. (2017) Analysis of results from the global, 5-year Easypod™ Connect Observational Study (ECOS) study in children with growth disorders. 10th International Meeting for Pediatric Endocrinology; 2017 Sep 14-17; Washington, DC.
citation: Wit, JM. et al. (2017) Effect of adherence on the 2-year growth response to growth hormone treatment in prepubertal children with idiopathic isolated growth hormone deficiency participating in the EasypodTM Connect Observational Study (ECOS). 10th International Meeting of Paediatric Endocrinology; 2017 Sep 14-17; Washington, DC.
responsible party type: Sponsor
mesh term: Growth Disorders