<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/NCT03013166</url>
  </required_header>
  <id_info>
    <org_study_id>SHP617-701</org_study_id>
    <nct_id>NCT03013166</nct_id>
  </id_info>
  <brief_title>THIN Database Study: Resource Use and Outcomes in Patients With Adrenal Insufficiency Prescribed Hydrocortisone: Immediate, or Modified Release, or Prednisolone</brief_title>
  <official_title>Resource Use and Clinical Outcomes in Patients With Adrenal Insufficiency Prescribed Either an Immediate Release or Modified Release Hydrocortisone Formulation or Prednisolone: A THIN (The Health Improvement Network) Database Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To describe clinical outcomes and both primary and secondary care health care resource use in&#xD;
      patients who have been prescribed either immediate-release (IR) hydrocortisone or&#xD;
      modified-release (MR) hydrocortisone or prednisolone in the UK.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">December 1, 2016</completion_date>
  <primary_completion_date type="Actual">December 1, 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary care resource use per year in all patients as measured by using number of primary care contacts</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary care resource use per year in all patients as measured by number of referrals to secondary care (by specialty)</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary care resource use per year in all patients as measured by number of sick notes issues</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">3000</enrollment>
  <condition>Adrenal Insufficiency</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>IR hydrocortisone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <description>IR prednisolone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <description>MR hydrocortisone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4</arm_group_label>
    <description>IR to MR hydrocortisone</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Corticosteroid medication</intervention_name>
    <description>Patients will be grouped into Cohort 1 (IR hydrocortisone), cohort 2 (IR prednisolone), cohort 3 (MR hydrocortisone), or cohort 4 (IR to MR hydrocortisone) depending on which oral corticosteroid medications were received during the observation period.</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_label>Cohort 4</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients in the THIN database who have a Read code for AI and have been prescribed&#xD;
        either IR hydrocortisone or prednisolone or MR hydrocortisone (plenadren) between 2010 and&#xD;
        the date of data extraction will be included&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cohort 1 (IR hydrocortisone): All patients with a Read code for AI and a prescription&#xD;
             of IR hydrocortisone between 2010 and data extraction but no prescription for MR&#xD;
             hydrocortisone at any time during this period, and no earlier prescription for IR&#xD;
             prednisolone during this period&#xD;
&#xD;
          2. Cohort 2 (IR prednisolone): All patients with a Read code for AI and a prescription of&#xD;
             IR prednisolone between 2010 and data extraction but no prescription for MR&#xD;
             prednisolone at any time during this period, and no earlier prescription for IR&#xD;
             prednisolone during this period&#xD;
&#xD;
          3. Cohort 3a (MR Hydrocortisone): All patients with a Read code for AI and a prescription&#xD;
             of MR hydrocortisone between 2010 and data extraction&#xD;
&#xD;
          4. Cohort 3b (IR to MR hydrocortisone): A sub-set of patients from cohort 3a, who have&#xD;
             switched from IR to MR hydrocortisone.&#xD;
&#xD;
          5. A list of pre-defined READ codes will be used to identify all patients with primary or&#xD;
             secondary AI or CAH in the THIN database.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1)Patients who have not received a prescription of hydrocortisone or prednisolone in the&#xD;
        past five years will be excluded as the aim of the study is to describe recent experience.&#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>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>October 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>May 30, 2021</last_update_submitted>
  <last_update_submitted_qc>May 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2021</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>Adrenal Insufficiency</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/NCT03013166
org study id: SHP617-701
nct id: NCT03013166
lead sponsor: 
has dmc: No
To describe clinical outcomes and both primary and secondary care health care resource use in
      patients who have been prescribed either immediate-release (IR) hydrocortisone or
      modified-release (MR) hydrocortisone or prednisolone in the UK.
observational model: Cohort
time perspective: Retrospective
measure: Primary care resource use per year in all patients as measured by using number of primary care contacts
time frame: 4 months
measure: Primary care resource use per year in all patients as measured by number of referrals to secondary care (by specialty)
time frame: 4 months
measure: Primary care resource use per year in all patients as measured by number of sick notes issues
time frame: 4 months
arm group label: Cohort 1
description: IR hydrocortisone
arm group label: Cohort 2
description: IR prednisolone
arm group label: Cohort 3
description: MR hydrocortisone
arm group label: Cohort 4
description: IR to MR hydrocortisone
intervention type: Other
intervention name: Corticosteroid medication
description: Patients will be grouped into Cohort 1 (IR hydrocortisone), cohort 2 (IR prednisolone), cohort 3 (MR hydrocortisone), or cohort 4 (IR to MR hydrocortisone) depending on which oral corticosteroid medications were received during the observation period.
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
arm group label: Cohort 4
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
responsible party type: Sponsor
mesh term: Adrenal Insufficiency