<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/NCT02235987</url>
  </required_header>
  <id_info>
    <org_study_id>DG3173-II-01</org_study_id>
    <nct_id>NCT02235987</nct_id>
  </id_info>
  <brief_title>Single Dose Pharmacology Study of DG3173 and Octreotide in Acromegalic Patients.</brief_title>
  <official_title>A Study of the Effect of Ascending Single Doses of DG3173 and 300 μg of Octreotide on Human Growth Hormone Levels in Untreated Acromegalics.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aspireo Pharmaceuticals Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aspireo Pharmaceuticals Limited</source>
  <brief_summary>
    <textblock>
      The study is designed to investigate the safety, tolerability and efficacy of DG3173 in&#xD;
      untreated acromegaly patients. Twenty patients received ascending single doses of DG3173 and&#xD;
      one dose of octreotide, the current gold standard of medical therapy for acromegaly, with&#xD;
      each patient receiving all doses of DG3173 as well as octreotide.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants With Trough Human Growth Hormone &lt; 2.5 ug/mL</measure>
    <time_frame>Pre dose and 0.33, 0.67 hours and 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post dose on each dosing day.</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Acromegaly</condition>
  <arm_group>
    <arm_group_label>Octreotide, then ascending DG3173</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Interventions: octreotide and DG3173. Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>octreotide</intervention_name>
    <description>Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.</description>
    <arm_group_label>Octreotide, then ascending DG3173</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DG3173</intervention_name>
    <description>Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.</description>
    <arm_group_label>Octreotide, then ascending DG3173</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men, women of non childbearing potential or women of child bearing potential who&#xD;
             either abstain from sexual intercourse, have a sterile partner or practice a medically&#xD;
             approved double barrier method of contraception&#xD;
&#xD;
          -  Diagnosis of acromegaly of pituitary origin&#xD;
&#xD;
          -  Have age adjusted Insulin like Growth Factor 1 (IGF-1) concentrations ≥1.5 times the&#xD;
             upper limit of normal range on two consecutive measurements in the 6 months prior to&#xD;
             the first dosing day (including the measurement to be made at screening [Visit 2])&#xD;
&#xD;
          -  Have a random hGH level of ≥5 µg/L in the 6 months prior to or at screening (Visit 2)&#xD;
&#xD;
          -  Have given written informed consent&#xD;
&#xD;
          -  Ability to comply with the requirements of the protocol of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous specific treatment for acromegaly in the 6 months prior to screening (Visit&#xD;
             2), including somatostatin analogues (SSAs), surgery, radiotherapy and pegvisomant&#xD;
&#xD;
          -  Treatment with dopamine agonists in the 3 months prior to screening (Visit 2)&#xD;
&#xD;
          -  Uncontrolled hypertension or orthostatic hypotension&#xD;
&#xD;
          -  Type I diabetes mellitus, poorly-controlled type II diabetes mellitus (glycosylated&#xD;
             haemoglobin [HbA1c]≥7.5%) and patients requiring insulin treatment&#xD;
&#xD;
          -  Gallstones or gravel that could cause biliary obstruction&#xD;
&#xD;
          -  Hyperprolactinaemia&#xD;
&#xD;
          -  Participation in a clinical study within 60 days prior to screening (Visit 2)&#xD;
&#xD;
          -  Receipt of blood, blood products or plasma derivatives 60 days prior to screening&#xD;
             (Visit 2)&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  A history of active alcohol abuse or drug addiction&#xD;
&#xD;
          -  Positive viral serology screening result for hepatitis B surface antigen, antibodies&#xD;
             to hepatitis C virus, or human immunodeficiency virus type 1 and 2&#xD;
&#xD;
          -  Evidence or suspicion of tumour expansion&#xD;
&#xD;
          -  Clinically significant abnormality in screening ECG&#xD;
&#xD;
          -  Any clinically significant abnormal laboratory safety test (biochemistry, haematology&#xD;
             and dipstick urinalysis) in the opinion of the Investigator&#xD;
&#xD;
          -  Any disease which in the Investigator's opinion would exclude the patient from the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <results_first_submitted>June 7, 2016</results_first_submitted>
  <results_first_submitted_qc>January 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 15, 2018</results_first_posted>
  <last_update_submitted>January 19, 2018</last_update_submitted>
  <last_update_submitted_qc>January 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 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>Acromegaly</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Octreotide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Octreotide, Then Ascending DG3173</title>
          <description>Interventions: octreotide and DG3173. Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Octreotide</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received 100 µg DG3173</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received 300 µg DG3173</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received 900 µg DG3173</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received 1800 µg DG3173</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cross-over</title>
          <description>Interventions: octreotide and DG3173. Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.8" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Participants With Trough Human Growth Hormone &lt; 2.5 ug/mL</title>
        <time_frame>Pre dose and 0.33, 0.67 hours and 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post dose on each dosing day.</time_frame>
        <population>Baseline: an 8 hour untreated human growth hormone (hGH) profile was obtained in the period between 15 and 7 days prior to the first study treatment administration.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline (Untreated Control)</title>
          </group>
          <group group_id="O2">
            <title>300 µg Octreotide</title>
          </group>
          <group group_id="O3">
            <title>100 µg DG3173</title>
          </group>
          <group group_id="O4">
            <title>300 µg DG3173</title>
          </group>
          <group group_id="O5">
            <title>900 µg DG3173</title>
          </group>
          <group group_id="O6">
            <title>1800 µg DG3173</title>
          </group>
        </group_list>
        <measure>
          <title>Participants With Trough Human Growth Hormone &lt; 2.5 ug/mL</title>
          <population>Baseline: an 8 hour untreated human growth hormone (hGH) profile was obtained in the period between 15 and 7 days prior to the first study treatment administration.</population>
          <units>participants with trough hGH &lt; 2.5 µg/mL</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>300 µg Octreotide</title>
        </group>
        <group group_id="E2">
          <title>100 µg DG3173</title>
        </group>
        <group group_id="E3">
          <title>300 µg DG3173</title>
        </group>
        <group group_id="E4">
          <title>900 µg DG3173</title>
        </group>
        <group group_id="E5">
          <title>1800 µg DG3173</title>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperamylasemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Fredric Cohen, MD</name_or_title>
      <organization>Strongbridge Biopharma</organization>
      <phone>610-254-9200</phone>
      <email>f.cohen@strongbridgebio.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02235987
org study id: DG3173-II-01
nct id: NCT02235987
lead sponsor: 
The study is designed to investigate the safety, tolerability and efficacy of DG3173 in
      untreated acromegaly patients. Twenty patients received ascending single doses of DG3173 and
      one dose of octreotide, the current gold standard of medical therapy for acromegaly, with
      each patient receiving all doses of DG3173 as well as octreotide.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Participants With Trough Human Growth Hormone < 2.5 ug/mL
time frame: Pre dose and 0.33, 0.67 hours and 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post dose on each dosing day.
arm group label: Octreotide, then ascending DG3173
arm group type: Other
description: Interventions: octreotide and DG3173. Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.
intervention type: Drug
intervention name: octreotide
description: Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.
arm group label: Octreotide, then ascending DG3173
intervention type: Drug
intervention name: DG3173
description: Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.
arm group label: Octreotide, then ascending DG3173
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Acromegaly
mesh term: Octreotide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 