<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/NCT03017690</url>
  </required_header>
  <id_info>
    <org_study_id>A-US-52030-358</org_study_id>
    <nct_id>NCT03017690</nct_id>
  </id_info>
  <brief_title>Lanreotide and Octreotide Long Acting Release (LAR) for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)</brief_title>
  <official_title>Lanreotide and Octreotide LAR for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): An Observational Time and Motion Analysis</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>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An observational time and motion study in a clinical oncology setting is utilized in order to&#xD;
      measure and compare product attributes and overall product efficiency between lanreotide and&#xD;
      octreotide LAR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2017</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The total time for product preparation and administration</measure>
    <time_frame>Day 1</time_frame>
    <description>Total drug delivery time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total patient wait time for administration</measure>
    <time_frame>Day 1</time_frame>
    <description>For the purposes of this study, &quot;total patient wait time&quot; refers to the time the patient checks in at the infusion room until completion of drug administration and discharge of the patient from the infusion room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clogging episodes</measure>
    <time_frame>Day 1</time_frame>
    <description>The number of clogging episodes for lanreotide and octreotide LAR will be recorded and compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare resource utilization</measure>
    <time_frame>Day 1</time_frame>
    <description>The materials used for the preparation of lanreotide and octreotide LAR will be recorded and compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacist and/or nurse satisfaction and product preference</measure>
    <time_frame>Day 1 and at the end of the study (approximately 3 months)</time_frame>
    <description>Assessed by pharmacist and/or nurse completing questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Day 1</time_frame>
    <description>Assessed by patient completing questionnaire</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">22</enrollment>
  <condition>Gastroenteropancreatic Neuroendocrine Tumor</condition>
  <arm_group>
    <arm_group_label>lanreotide group (Somatuline Depot®)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>octreotide LAR group (Sandostatin LAR®)</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited through US institutions/clinics that commonly treat&#xD;
        neuroendocrine tumor patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women must be 18 years of age or older&#xD;
&#xD;
          -  A current diagnosis of advanced, unresectable GEP-NET&#xD;
&#xD;
          -  Provided written informed consent to participate in the study&#xD;
&#xD;
          -  Currently receiving lanreotide or octreotide LAR and has received at least one prior&#xD;
             injection of current somatostatin analogues (SSA).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving treatment with lanreotide or octreotide LAR as part of a clinical trial&#xD;
&#xD;
          -  Scheduled to receive a dose of lanreotide or octreotide LAR that would necessitate&#xD;
             more than 1 injection on the same day&#xD;
&#xD;
          -  Scheduled to receive any other treatment in the infusion center/room on the same day&#xD;
             and as part of the same appointment&#xD;
&#xD;
          -  Known hypersensitivity to somatostatin analogues&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ipsen Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Ipsen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center Kenner</name>
      <address>
        <city>Kenner</city>
        <state>Louisiana</state>
        <zip>70065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Translational Research Group</name>
      <address>
        <city>East Setauket</city>
        <state>New York</state>
        <zip>11733</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Specialists of Charlotte</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</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>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Intestinal Neoplasms</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</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/NCT03017690
org study id: A-US-52030-358
nct id: NCT03017690
lead sponsor: 
has dmc: No
is fda regulated device: No
An observational time and motion study in a clinical oncology setting is utilized in order to
      measure and compare product attributes and overall product efficiency between lanreotide and
      octreotide LAR.
observational model: Cohort
time perspective: Cross-Sectional
measure: The total time for product preparation and administration
time frame: Day 1
description: Total drug delivery time
measure: Total patient wait time for administration
time frame: Day 1
description: For the purposes of this study, "total patient wait time" refers to the time the patient checks in at the infusion room until completion of drug administration and discharge of the patient from the infusion room.
measure: Number of clogging episodes
time frame: Day 1
description: The number of clogging episodes for lanreotide and octreotide LAR will be recorded and compared.
measure: Healthcare resource utilization
time frame: Day 1
description: The materials used for the preparation of lanreotide and octreotide LAR will be recorded and compared.
measure: Pharmacist and/or nurse satisfaction and product preference
time frame: Day 1 and at the end of the study (approximately 3 months)
description: Assessed by pharmacist and/or nurse completing questionnaire
measure: Patient satisfaction
time frame: Day 1
description: Assessed by patient completing questionnaire
arm group label: lanreotide group (Somatuline Depot®)
arm group label: octreotide LAR group (Sandostatin LAR®)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ipsen Medical Director
role: Study Director
affiliation: Ipsen
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neuroendocrine Tumors
mesh term: Intestinal Neoplasms
mesh term: Pancreatic Neoplasms
mesh term: Stomach Neoplasms