<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/NCT02246816</url>
  </required_header>
  <id_info>
    <org_study_id>MP-101-CL-002OLE</org_study_id>
    <nct_id>NCT02246816</nct_id>
  </id_info>
  <brief_title>A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001</brief_title>
  <official_title>A Phase 3, Open Label Extension Study for Subjects That Complete Study MP-101-CL-001</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marathon Pharmaceuticals, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marathon Pharmaceuticals, LLC</source>
  <brief_summary>
    <textblock>
      MP-101 will be evaluated in this study to see if it is safe and tolerable.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Transfer of IND to different marketing authorization representative.&#xD;
  </why_stopped>
  <start_date>February 2015</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>Up to 120 Days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Short Bowel Syndrome</condition>
  <condition>Short Gut Syndrome</condition>
  <condition>SBS</condition>
  <condition>Short Gut</condition>
  <arm_group>
    <arm_group_label>All Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assigned to receive open-label 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)</intervention_name>
    <description>0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)</description>
    <arm_group_label>All Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be male or female adults, 18 years of age or older&#xD;
&#xD;
          -  Have SBS that is inadequately controlled on current antidiarrheal medication (e.g.,&#xD;
             loperamide or diphenoxylate), including subjects with ileostomies&#xD;
&#xD;
          -  Must have been deemed a completer of study protocol MP-101-CL-001.&#xD;
&#xD;
          -  Males or non-pregnant, non-lactating females who are postmenopausal, naturally or&#xD;
             surgically sterile, or who agree to use effective contraceptive methods throughout the&#xD;
             course of the study. Postmenopausal is defined as at least 12 months of natural&#xD;
             spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral&#xD;
             oophorectomy)&#xD;
&#xD;
          -  Females of childbearing potential must agree to use 1 of the following acceptable&#xD;
             birth control methods:&#xD;
&#xD;
               -  Surgically sterile (hysterectomy or bilateral oophorectomy)&#xD;
&#xD;
               -  Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior&#xD;
                  to study initiation)&#xD;
&#xD;
               -  Intrauterine device (IUD) in place for at least 3 months&#xD;
&#xD;
               -  Abstinence (not having sexual intercourse)&#xD;
&#xD;
               -  Barrier method (condom or diaphragm) with spermicide for at least 14 days prior&#xD;
                  to screening and through study completion&#xD;
&#xD;
               -  Stable hormonal contraceptive for at least 3 months prior to study and through&#xD;
                  study completion&#xD;
&#xD;
               -  Vasectomized partner&#xD;
&#xD;
          -  Females of childbearing potential must have a negative serum human chorionic&#xD;
             gonadotropin (hCG) pregnancy test at Visit 1.&#xD;
&#xD;
          -  Be able to understand and provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any history of or active neurological, endocrine, cardiovascular, pulmonary,&#xD;
             hematological, immunologic, psychiatric, or metabolic disease that is considered&#xD;
             clinically significant, is not currently controlled by medication, and is stable as&#xD;
             deemed by the Investigator&#xD;
&#xD;
          -  Are currently taking antibiotics for bacterial overgrowth&#xD;
&#xD;
          -  Have known or suspected pregnancy, planned pregnancy, or lactation&#xD;
&#xD;
          -  Have a planned surgery during the course of the study&#xD;
&#xD;
          -  Have a condition the Investigator believes would interfere with the ability to provide&#xD;
             informed consent or comply with study instructions, or that might confound the&#xD;
             interpretation of the study results or put the subject at undue risk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Infectious Disease Infusion Center</name>
      <address>
        <city>Lima</city>
        <state>Ohio</state>
        <zip>45801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Center for Human Nutrition</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212-1150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>February 16, 2015</last_update_submitted>
  <last_update_submitted_qc>February 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Short Bowel Syndrome</keyword>
  <keyword>SBS</keyword>
  <keyword>Chronic Diarrhea</keyword>
  <keyword>Short Bowel</keyword>
  <keyword>Short Gut</keyword>
  <keyword>Short Gut Syndrome</keyword>
  <keyword>Anti-Diarrheal</keyword>
  <keyword>Opium Tincture</keyword>
  <keyword>loperamide</keyword>
  <keyword>diphenoxylate</keyword>
  <keyword>ileostomies</keyword>
  <keyword>tincture of opium</keyword>
  <keyword>DTO</keyword>
  <keyword>codeine</keyword>
  <keyword>morphine</keyword>
  <keyword>opiate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Short Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opium</mesh_term>
  </intervention_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/NCT02246816
org study id: MP-101-CL-002OLE
nct id: NCT02246816
lead sponsor: 
MP-101 will be evaluated in this study to see if it is safe and tolerable.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Adverse Events
time frame: Up to 120 Days
arm group label: All Subjects
arm group type: Experimental
description: Assigned to receive open-label 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)
intervention type: Drug
intervention name: 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)
description: 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)
arm group label: All Subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Short Bowel Syndrome
mesh term: Syndrome
mesh term: Opium