<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/NCT02263365</url>
  </required_header>
  <id_info>
    <org_study_id>Loperamide Dehydration</org_study_id>
    <nct_id>NCT02263365</nct_id>
  </id_info>
  <brief_title>Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies</brief_title>
  <official_title>Prospective Randomized Control Study on Effect of Post Operative Loperamide in Decreasing Readmission for Dehydration in Colorectal Patients After Diverting Ileostomies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced&#xD;
      by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and&#xD;
      familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal cancers or&#xD;
      other polyposis syndromes e.g. HNPCC hereditary non polyposis colorectal cancers, may&#xD;
      potentially have a delay in the adjuvant therapy when faced with this complication.&#xD;
&#xD;
      Studies performed in this groups of patients report a readmission rate of 17-21% for&#xD;
      dehydration.&#xD;
&#xD;
      Loperamide has been shown to significantly decrease the daily volume of weight of stool in&#xD;
      these patients.&#xD;
&#xD;
      The purpose of this study is to establish whether loperamide given at 4mg three times daily&#xD;
      for 14 days from day of discharge empirically decreases 30 days readmission rate for&#xD;
      dehydration.&#xD;
&#xD;
      The investigators hypothesize that there will be a 15% decrease from 25% to 10% in the&#xD;
      readmission rates, that severity of dehydration will be decreased.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to meet study requirements&#xD;
  </why_stopped>
  <start_date type="Actual">October 7, 2014</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of 30 Day Readmission (Severe Dehydration)</measure>
    <time_frame>30 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/&lt;24hrs That Did Not Require Hospital Admission</measure>
    <time_frame>30 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of Index Admission</measure>
    <time_frame>30 day</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Dehydration, Diverting Ileostomy, Loperamide</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Therapeutic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Loperamide</intervention_name>
    <description>Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge</description>
    <arm_group_label>Therapeutic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to freely give written informed consent to participate in the study and have&#xD;
             signed the Informed Consent Form;&#xD;
&#xD;
          2. Males or females, age 18 and older at the time of study screening;&#xD;
&#xD;
          3. American Society of Anesthesiologists (ASA) Class I-III (Appendix III) undergoing&#xD;
             elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mentally incompetent or unable or unwilling to provide informed consent or comply with&#xD;
             study procedures&#xD;
&#xD;
          2. American Society of Anesthesiologists (ASA) Class IV or V; emergency surgeries&#xD;
&#xD;
          3. Children &lt;18&#xD;
&#xD;
          4. Pregnant patients&#xD;
&#xD;
          5. Patients who have intra-abdominal sepsis or partial or intermittent bowel obstruction&#xD;
             or enteritis&#xD;
&#xD;
          6. Patients who are on long term steroids, opioids or antidiarrheals pre operatively&#xD;
&#xD;
          7. Patients who are administered pro kinetics eg. Metoclopramide&#xD;
&#xD;
          8. Patients with recurrent disease in their small bowel - Crohn's disease, or previous&#xD;
             irradiated pelvis resulting in irradiation bowel disease&#xD;
&#xD;
          9. End ileostomies&#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>Philip R Fleshner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <results_first_submitted>October 10, 2017</results_first_submitted>
  <results_first_submitted_qc>November 22, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 20, 2017</results_first_posted>
  <last_update_submitted>November 22, 2017</last_update_submitted>
  <last_update_submitted_qc>November 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Phillip Fleshner MD</investigator_full_name>
    <investigator_title>Director of Colorectal Residency</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dehydration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loperamide</mesh_term>
    <mesh_term>Antidiarrheals</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>No intervention</description>
        </group>
        <group group_id="P2">
          <title>Therapeutic</title>
          <description>Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered&#xD;
Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Data was not collected.</population>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>No intervention</description>
        </group>
        <group group_id="B2">
          <title>Therapeutic</title>
          <description>Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered&#xD;
Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <class_list>
            <class>
              <title>United States</title>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of 30 Day Readmission (Severe Dehydration)</title>
        <time_frame>30 day</time_frame>
        <population>Data was not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>No intervention</description>
          </group>
          <group group_id="O2">
            <title>Therapeutic</title>
            <description>Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered&#xD;
Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of 30 Day Readmission (Severe Dehydration)</title>
          <population>Data was not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/&lt;24hrs That Did Not Require Hospital Admission</title>
        <time_frame>30 day</time_frame>
        <population>Data was not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
          </group>
          <group group_id="O2">
            <title>Therapeutic</title>
            <description>Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered&#xD;
Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/&lt;24hrs That Did Not Require Hospital Admission</title>
          <population>Data was not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care</title>
        <time_frame>30 days</time_frame>
        <population>Data was not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
          </group>
          <group group_id="O2">
            <title>Therapeutic</title>
            <description>Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered&#xD;
Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care</title>
          <population>Data was not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Length of Index Admission</title>
        <time_frame>30 day</time_frame>
        <population>Data was not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
          </group>
          <group group_id="O2">
            <title>Therapeutic</title>
            <description>Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered&#xD;
Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Index Admission</title>
          <population>Data was not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Data was not collected. Study was terminated prematurely due to issued with compliance. Total number of participants at Risk (e.g., &quot; All-Cause Mortality, Serious, and other [not including serious] adverse events were not monitored/assessed for this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>No intervention</description>
        </group>
        <group group_id="E2">
          <title>Therapeutic</title>
          <description>Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered&#xD;
Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>
    <limitations_and_caveats>Study only accrued 40 patients. Due to issues with enrollment and study procedures compliance it was decided to terminate the study. Data analysis will not be done for this study. This study has been closed with the internal review board.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Phillip Fleshner, MD</name_or_title>
      <organization>Cedars Sinai Medical Center</organization>
      <phone>310-289-9224</phone>
      <email>pfleshner@aol.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/NCT02263365
org study id: Loperamide Dehydration
nct id: NCT02263365
lead sponsor: 
has dmc: No
Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced
      by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and
      familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal cancers or
      other polyposis syndromes e.g. HNPCC hereditary non polyposis colorectal cancers, may
      potentially have a delay in the adjuvant therapy when faced with this complication.

      Studies performed in this groups of patients report a readmission rate of 17-21% for
      dehydration.

      Loperamide has been shown to significantly decrease the daily volume of weight of stool in
      these patients.

      The purpose of this study is to establish whether loperamide given at 4mg three times daily
      for 14 days from day of discharge empirically decreases 30 days readmission rate for
      dehydration.

      The investigators hypothesize that there will be a 15% decrease from 25% to 10% in the
      readmission rates, that severity of dehydration will be decreased.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of 30 Day Readmission (Severe Dehydration)
time frame: 30 day
measure: Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission
time frame: 30 day
measure: Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care
time frame: 30 days
measure: Length of Index Admission
time frame: 30 day
arm group label: Control
arm group type: No Intervention
arm group label: Therapeutic
arm group type: Experimental
description: Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered
intervention type: Drug
intervention name: Loperamide
description: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge
arm group label: Therapeutic
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philip R Fleshner, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Phillip Fleshner MD
investigator title: Director of Colorectal Residency
mesh term: Dehydration
mesh term: Loperamide
mesh term: Antidiarrheals
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study only accrued 40 patients. Due to issues with enrollment and study procedures compliance it was decided to terminate the study. Data analysis will not be done for this study. This study has been closed with the internal review board.
point of contact: 