<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/NCT01704651</url>
  </required_header>
  <id_info>
    <org_study_id>12-004082</org_study_id>
    <nct_id>NCT01704651</nct_id>
  </id_info>
  <brief_title>Accelerating Gastrointestinal Recovery</brief_title>
  <official_title>Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jamie N. Bakkum-Gamez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cubist Pharmaceuticals LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to determine whether an oral perioperative medication (alvimopan--a&#xD;
      selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Length of Hospital Stay</measure>
    <time_frame>Patients will be followed for the duration of their hospital stay, an expected average of 5 days</time_frame>
    <description>Length of stay = date/time of hospital dismissal - date/time of end of surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Ileus Incidence</measure>
    <time_frame>Patients will be followed for 30 days postop</time_frame>
    <description>Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Fallopian Tube Cancer</condition>
  <condition>Peritoneal Cancer</condition>
  <arm_group>
    <arm_group_label>Alvimopan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Perioperative administration of placebo, at same dosing interval as study drug.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alvimopan</intervention_name>
    <description>Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.</description>
    <arm_group_label>Alvimopan</arm_group_label>
    <other_name>Entereg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Perioperative administration of placebo, at same dosing interval as study drug.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Females at least 18 years of age&#xD;
&#xD;
          -  Have an American Society of Anesthesiologists (ASA) Score of I to III&#xD;
&#xD;
          -  Are consented for primary, interval, or secondary cytoreduction for ovarian, tubal, or&#xD;
             peritoneal cancer&#xD;
&#xD;
          -  Are scheduled to have their nasogastric tube removed before the first postoperative&#xD;
             dose of study medication&#xD;
&#xD;
          -  Are able to understand the study procedures, have agreed to participate in the study&#xD;
             program, and have voluntarily provided informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Females younger than 18 years of age&#xD;
&#xD;
          -  Known non-gynecologic malignancy presenting with similar signs/symptoms as ovarian,&#xD;
             tubal, or peritoneal cancer.&#xD;
&#xD;
          -  Have taken more than 7 consecutive days of therapeutic doses of opioids immediately&#xD;
             prior to surgery&#xD;
&#xD;
          -  Use illicit drugs or abuse alcohol&#xD;
&#xD;
          -  Have had a prior total colectomy, gastrectomy, gastric bypass, or have a functional&#xD;
             colostomy or ileostomy&#xD;
&#xD;
          -  Have an ongoing history of short bowel syndrome, chronic constipation (≤3 spontaneous&#xD;
             bowel movements per week) or chronic diarrhea&#xD;
&#xD;
          -  Have received radiation therapy to the abdomen or pelvis within 3 months of scheduled&#xD;
             surgery&#xD;
&#xD;
          -  Have chemotherapy or radiation induced bowel dysfunction&#xD;
&#xD;
          -  Are pregnant (identified by a positive urine or serum pregnancy test) or lactating, or&#xD;
             are not postmenopausal (no menses for at least 1 year) and are of childbearing&#xD;
             potential and not using an accepted method of birth control (ie, surgical&#xD;
             sterilization, intrauterine contraceptive device, oral contraceptive, diaphragm, or&#xD;
             condom in combination with contraceptive cream, jelly, or foam, or abstinence)&#xD;
&#xD;
          -  Have participated in another investigational drug or medical device study within 30&#xD;
             days of surgery or will be enrolled in another investigational drug or medical device&#xD;
             study or any study in which active patient participation is required outside normal&#xD;
             hospital data collection during the course of this study&#xD;
&#xD;
          -  Have clinically significant laboratory abnormalities at screening that would result in&#xD;
             the cancellation of surgery&#xD;
&#xD;
          -  Have a diagnosis of severe hepatic insufficiency or end stage renal disease.&#xD;
&#xD;
          -  Have a history of previous surgeries, illness, or behavior that in the opinion of the&#xD;
             investigator might confound the study results or pose additional risk in administering&#xD;
             the study procedures&#xD;
&#xD;
          -  Are unable to understand the study procedures and are not able to voluntarily provided&#xD;
             informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jamie Bakkum-Gamez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>October 7, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <results_first_submitted>August 30, 2016</results_first_submitted>
  <results_first_submitted_qc>August 30, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 24, 2016</results_first_posted>
  <last_update_submitted>August 30, 2016</last_update_submitted>
  <last_update_submitted_qc>August 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Jamie N. Bakkum-Gamez</investigator_full_name>
    <investigator_title>Consultant and Assistant Professor of Obstetrics-Gynecology,</investigator_title>
  </responsible_party>
  <keyword>Ovary</keyword>
  <keyword>Ovarian</keyword>
  <keyword>Fallopian</keyword>
  <keyword>Peritoneal</keyword>
  <keyword>Cancer</keyword>
  <keyword>Gynecological</keyword>
  <keyword>Female</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fallopian Tube Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alvimopan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study took place at Mayo Clinic in Rochester, Minnesota from January 2013 to June 2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Alvimopan</title>
          <description>Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Perioperative administration of placebo, at same dosing interval as study drug.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pre-op withdrawal by subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pre-op change in treatment plan</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Nasogastric tube placement in surgery</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Post-op did not have laparotomy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics are provided for the subjects who completed study follow up.</population>
      <group_list>
        <group group_id="B1">
          <title>Alvimopan</title>
          <description>Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Perioperative administration of placebo, at same dosing interval as study drug.</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="66"/>
            <count group_id="B2" value="68"/>
            <count group_id="B3" value="134"/>
          </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="60.4" spread="10.2"/>
                    <measurement group_id="B2" value="63.7" spread="11.2"/>
                    <measurement group_id="B3" value="62.1" spread="10.8"/>
                  </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="66"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Surgery Type</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Primary surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interval debulking</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary debulking</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cancer Stage</title>
          <description>Cancer Stage used the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system. For ovarian cancer, there are 4 stages: stage I: confined to the organ of origin, stage II: invasion of surrounding organs or tissue, stage III: spread to distant nodes or tissue within the pelvis, stage IV: distant metastasis(es)</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>I/II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>III/IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other non-ovarian primary cancers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Benign pelvic masses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recurrent disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Residual Disease</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes, measurable (&lt;/= 1 cm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes, suboptimal (&gt;1 cm, limited sites)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes, extensive (multiple sites/organs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Length of Hospital Stay</title>
        <description>Length of stay = date/time of hospital dismissal - date/time of end of surgery</description>
        <time_frame>Patients will be followed for the duration of their hospital stay, an expected average of 5 days</time_frame>
        <population>Intent to Treat analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Alvimopan</title>
            <description>Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Perioperative administration of placebo, at same dosing interval as study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Length of Hospital Stay</title>
          <description>Length of stay = date/time of hospital dismissal - date/time of end of surgery</description>
          <population>Intent to Treat analysis</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="2.7"/>
                    <measurement group_id="O2" value="4.3" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.34</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Ileus Incidence</title>
        <description>Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.</description>
        <time_frame>Patients will be followed for 30 days postop</time_frame>
        <population>Intent to treat analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Alvimopan</title>
            <description>Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Perioperative administration of placebo, at same dosing interval as study drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Ileus Incidence</title>
          <description>Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.</description>
          <population>Intent to treat analysis</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.17</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from administration of first dose of study medication through 30 days following last dose of study medication.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Alvimopan</title>
          <description>Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days..</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Electrolyte Imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Malaise (Failure to thrive)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Fluid Retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mania</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic Fluid Collection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Wound Dehiscence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Wound Complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="57" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Increased international normalized ratio (INR)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Lymphedema</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="66"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Lymphangitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="25" subjects_affected="25" subjects_at_risk="66"/>
                <counts group_id="E2" events="27" subjects_affected="27" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Arrhythmias</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pulmonary Edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Biliary Leak</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="66"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="66"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="66"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="66"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="66"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Esophagitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Gastroparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Small Bowel Obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Small Bowel Perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Weight Loss</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction to chemo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Electrolyte Imbalance</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="66"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Elevated Liver Enzymes</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Generalized Muscle Weakness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Neuropathy, sensory</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="66"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Cystotomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pelvic Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="66"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Urinary Incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Urinary Tract Obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Bladder Symptoms</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="66"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="66"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Pneumonthorax</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="66"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Wound Complication</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Vaginal Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Jamie N. Bakkum-Gamez</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-266-8661</phone>
      <email>Bakkum.Jamie@mayo.edu</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/NCT01704651
org study id: 12-004082
nct id: NCT01704651
lead sponsor: 
collaborator: 
has dmc: No
This study is designed to determine whether an oral perioperative medication (alvimopan--a
      selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian
      cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Postoperative Length of Hospital Stay
time frame: Patients will be followed for the duration of their hospital stay, an expected average of 5 days
description: Length of stay = date/time of hospital dismissal - date/time of end of surgery
measure: Postoperative Ileus Incidence
time frame: Patients will be followed for 30 days postop
description: Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.
arm group label: Alvimopan
arm group type: Experimental
description: Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Perioperative administration of placebo, at same dosing interval as study drug.
intervention type: Drug
intervention name: Alvimopan
description: Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.
arm group label: Alvimopan
other name: Entereg
intervention type: Drug
intervention name: Placebo
description: Perioperative administration of placebo, at same dosing interval as study drug.
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jamie Bakkum-Gamez, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Jamie N. Bakkum-Gamez
investigator title: Consultant and Assistant Professor of Obstetrics-Gynecology,
mesh term: Fallopian Tube Neoplasms
mesh term: Alvimopan
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 