<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/NCT02239510</url>
  </required_header>
  <id_info>
    <org_study_id>14040</org_study_id>
    <nct_id>NCT02239510</nct_id>
  </id_info>
  <brief_title>Efficacy of Linaclotide to Senna for CIC</brief_title>
  <official_title>A Randomized, Double-Blind, Trial Comparing the Efficacy of Linaclotide to Senna in Relieving Symptoms in Patients With Chronic Idiopathic Constipation (CIC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TriHealth Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TriHealth Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this prospective, randomized, double blind study, the aim is to determine the efficacy of&#xD;
      Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation&#xD;
      (CIC). Patients with CIC, (age 18 - 70) will be enrolled in the study and randomized to Senna&#xD;
      or Linaclotide. Patients will be asked to complete questionnaires during the study and will&#xD;
      be followed for 12 weeks. Main outcomes include number of daily bowel movements and measures&#xD;
      from surveys regarding bowel habits, relief, and satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective, randomized, double blind study, the aim is to determine the efficacy of&#xD;
      Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation&#xD;
      (CIC). Our hypothesis is that Senna is not inferior to Linaclotide in the treatment of CIC.&#xD;
      Seventy patients aged 18-70 diagnosed with CIC and seen by a gastroenterologist affiliated&#xD;
      with TriHealth or a patient of the Faculty Medical Center clinic will be included in the&#xD;
      study. After enrollment, subjects will be randomized to receive either Linaclotide or Senna&#xD;
      over a 12-week period after a 1 week wash-out period. During th study period, subjects will&#xD;
      complete a log to record the number of daily bowel movements. The subjects will also complete&#xD;
      3 validated surveys on a weekly basis: Subject's Global Assessment SGA of Relief, Subject's&#xD;
      Global Assessment SGA of Bowel Habit, and SGA of Satisfaction with their Bowel Habit. A&#xD;
      research nurse will meet with subjects at the beginning of the study and then at 3 monthly&#xD;
      visits to administer the study medication and distribute the surveys. The main outcomes&#xD;
      measures are change in # of bowel movements and SGA survey scores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not sufficient recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Number of Bowel Movements Per Week</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from before to after in number of weekly bowel movements</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Relief</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from before to after treatment in patient assessment of relief - The Subject's Global Assessment (SGA) of Relief was used to measure this outcome. In evaluating subject's response to SGA of relief, subject's who respond with either &quot;completely relieved&quot; or &quot;considerably relieved&quot; for at least 50% of the weeks at the end point or &quot;somewhat relieved&quot; for 100 % of the weeks at the end point will be considered responders to therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Assessment of Bowel Habit</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from before treatment to after treatment in assessment of bowel habit The Subject's Global Assessment (SGA) of Bowel Habit was used to measure this outcome. Patients were asked how bothersome their constipation was in the past week on a scare from 0 (Absent) to 100 (Very Severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Satisfaction With Bowel Habit</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change from before treatment to after treatment on patient satisfaction with bowel habit The Subject's Global Assessment (SGA) of Satisfaction with Bowel Habit was used to measure this outcome. Patients were asked how satisfied they have been with their bowel habits in the previous week on a scale of 0 (Unsatisfied) to 100 (Very Satisfied).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Chronic Idiopathic Constipation</condition>
  <arm_group>
    <arm_group_label>Senna</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 capsule (50 mg) Senna daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Linzess</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 capsule (145 mcg) once daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Senna</intervention_name>
    <description>1 capsule (50 mg) Senna daily for 12 weeks</description>
    <arm_group_label>Senna</arm_group_label>
    <other_name>sennoside</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Linzess</intervention_name>
    <description>1 capsule (145 mcg) of Linzess once daily for 12 weeks</description>
    <arm_group_label>Linzess</arm_group_label>
    <other_name>Linaclotide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Males and females 18 - 70 years of age. Diagnosed with CIC according to Rome III criteria.&#xD;
        Coherent and mentally competent patient to understand and consent for the trial&#xD;
        Unremarkable colonoscopy done in past 5 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Significant diarrhea (defined as loose or watery stool and or more than three bowel&#xD;
        movements daily associated with urgency more than 25% of the days in preceding 3 months)&#xD;
        Untreated hypothyroidism Organic or structural disease as the cause of patient's symptoms&#xD;
        (stricture or tumor) Diseases that affect bowel transit time (Gastroparesis, short bowel&#xD;
        syndrome) Evidence of cathartic colon History of alcohol, laxative abuse or illicit drug&#xD;
        use Pregnant or lactating women Planning pregnancy or become pregnant during study period&#xD;
        Concomitant use of any medication that could alter gastrointestinal motility (Calcium&#xD;
        channel blockers, Narcotics, anticholinergics, calcium and aluminium containing antacids,&#xD;
        phenothiazines, ferrous sulfate)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohd A AlSamman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TriHealth Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TriHealth</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>December 19, 2017</results_first_submitted>
  <results_first_submitted_qc>June 12, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 2, 2019</results_first_posted>
  <last_update_submitted>June 12, 2019</last_update_submitted>
  <last_update_submitted_qc>June 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>constipation</keyword>
  <keyword>bowel habits</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Linaclotide</mesh_term>
    <mesh_term>Sennosides</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Recruitment was low and therefore results are insufficient to share.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients enrolled from November 2014 to June 2015. A total of 16 patients were screened and 9 patients were enrolled. 3 patients did not show up to appointments and did not complete the study; 6 patients completed the study.</recruitment_details>
      <pre_assignment_details>1 week wash-out period after enrollment</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Senna</title>
          <description>Patients who received Senna</description>
        </group>
        <group group_id="P2">
          <title>Lizness</title>
          <description>Patients who received Lizness</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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>
      <group_list>
        <group group_id="B1">
          <title>Senna</title>
          <description>1 capsule (50 mg) Senna daily for 12 weeks&#xD;
Senna: 1 capsule (50 mg) Senna daily for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>Linzess</title>
          <description>1 capsule (145 mcg) once daily for 12 weeks&#xD;
Linzess: 1 capsule (145 mcg) of Linzess once daily for 12 weeks</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="3"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="50" spread="14.0"/>
                    <measurement group_id="B2" value="58" spread="10.1"/>
                    <measurement group_id="B3" value="54" spread="11.9"/>
                  </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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Number of Bowel Movements Per Week</title>
        <description>Change from before to after in number of weekly bowel movements</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Senna</title>
            <description>Patients who received Senna</description>
          </group>
          <group group_id="O2">
            <title>Lizness</title>
            <description>Patients who received Lizness</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Number of Bowel Movements Per Week</title>
          <description>Change from before to after in number of weekly bowel movements</description>
          <units>weekly bowel movements</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" spread=".7"/>
                    <measurement group_id="O2" value="2" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Relief</title>
        <description>Change from before to after treatment in patient assessment of relief - The Subject's Global Assessment (SGA) of Relief was used to measure this outcome. In evaluating subject's response to SGA of relief, subject's who respond with either &quot;completely relieved&quot; or &quot;considerably relieved&quot; for at least 50% of the weeks at the end point or &quot;somewhat relieved&quot; for 100 % of the weeks at the end point will be considered responders to therapy.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Senna</title>
            <description>Patients who received Senna</description>
          </group>
          <group group_id="O2">
            <title>Lizness</title>
            <description>Patients who received Lizness</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Relief</title>
          <description>Change from before to after treatment in patient assessment of relief - The Subject's Global Assessment (SGA) of Relief was used to measure this outcome. In evaluating subject's response to SGA of relief, subject's who respond with either &quot;completely relieved&quot; or &quot;considerably relieved&quot; for at least 50% of the weeks at the end point or &quot;somewhat relieved&quot; for 100 % of the weeks at the end point will be considered responders to therapy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Assessment of Bowel Habit</title>
        <description>Change from before treatment to after treatment in assessment of bowel habit The Subject's Global Assessment (SGA) of Bowel Habit was used to measure this outcome. Patients were asked how bothersome their constipation was in the past week on a scare from 0 (Absent) to 100 (Very Severe).</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Senna</title>
            <description>Patients who received Senna</description>
          </group>
          <group group_id="O2">
            <title>Lizness</title>
            <description>Patients who received Lizness</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Assessment of Bowel Habit</title>
          <description>Change from before treatment to after treatment in assessment of bowel habit The Subject's Global Assessment (SGA) of Bowel Habit was used to measure this outcome. Patients were asked how bothersome their constipation was in the past week on a scare from 0 (Absent) to 100 (Very Severe).</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.20" spread=".20"/>
                    <measurement group_id="O2" value="-.08" spread=".10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Satisfaction With Bowel Habit</title>
        <description>Change from before treatment to after treatment on patient satisfaction with bowel habit The Subject's Global Assessment (SGA) of Satisfaction with Bowel Habit was used to measure this outcome. Patients were asked how satisfied they have been with their bowel habits in the previous week on a scale of 0 (Unsatisfied) to 100 (Very Satisfied).</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Senna</title>
            <description>Patients who received Senna</description>
          </group>
          <group group_id="O2">
            <title>Lizness</title>
            <description>Patients who received Lizness</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Satisfaction With Bowel Habit</title>
          <description>Change from before treatment to after treatment on patient satisfaction with bowel habit The Subject's Global Assessment (SGA) of Satisfaction with Bowel Habit was used to measure this outcome. Patients were asked how satisfied they have been with their bowel habits in the previous week on a scale of 0 (Unsatisfied) to 100 (Very Satisfied).</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".23" spread=".32"/>
                    <measurement group_id="O2" value=".03" spread=".21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Senna</title>
          <description>Patients who received Senna</description>
        </group>
        <group group_id="E2">
          <title>Linzess</title>
          <description>Patients who received Linzess</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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jenni Steinbrunner</name_or_title>
      <organization>TriHealth Hatton Research Institute</organization>
      <phone>513-862-4033</phone>
      <email>jenni_steinbrunner@trihealth.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/NCT02239510
org study id: 14040
nct id: NCT02239510
lead sponsor: 
has dmc: No
In this prospective, randomized, double blind study, the aim is to determine the efficacy of
      Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation
      (CIC). Patients with CIC, (age 18 - 70) will be enrolled in the study and randomized to Senna
      or Linaclotide. Patients will be asked to complete questionnaires during the study and will
      be followed for 12 weeks. Main outcomes include number of daily bowel movements and measures
      from surveys regarding bowel habits, relief, and satisfaction.
In this prospective, randomized, double blind study, the aim is to determine the efficacy of
      Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation
      (CIC). Our hypothesis is that Senna is not inferior to Linaclotide in the treatment of CIC.
      Seventy patients aged 18-70 diagnosed with CIC and seen by a gastroenterologist affiliated
      with TriHealth or a patient of the Faculty Medical Center clinic will be included in the
      study. After enrollment, subjects will be randomized to receive either Linaclotide or Senna
      over a 12-week period after a 1 week wash-out period. During th study period, subjects will
      complete a log to record the number of daily bowel movements. The subjects will also complete
      3 validated surveys on a weekly basis: Subject's Global Assessment SGA of Relief, Subject's
      Global Assessment SGA of Bowel Habit, and SGA of Satisfaction with their Bowel Habit. A
      research nurse will meet with subjects at the beginning of the study and then at 3 monthly
      visits to administer the study medication and distribute the surveys. The main outcomes
      measures are change in # of bowel movements and SGA survey scores.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Number of Bowel Movements Per Week
time frame: 12 weeks
description: Change from before to after in number of weekly bowel movements
measure: Number of Participants With Relief
time frame: 12 weeks
description: Change from before to after treatment in patient assessment of relief - The Subject's Global Assessment (SGA) of Relief was used to measure this outcome. In evaluating subject's response to SGA of relief, subject's who respond with either "completely relieved" or "considerably relieved" for at least 50% of the weeks at the end point or "somewhat relieved" for 100 % of the weeks at the end point will be considered responders to therapy.
measure: Change in Assessment of Bowel Habit
time frame: 12 weeks
description: Change from before treatment to after treatment in assessment of bowel habit The Subject's Global Assessment (SGA) of Bowel Habit was used to measure this outcome. Patients were asked how bothersome their constipation was in the past week on a scare from 0 (Absent) to 100 (Very Severe).
measure: Change in Satisfaction With Bowel Habit
time frame: 12 weeks
description: Change from before treatment to after treatment on patient satisfaction with bowel habit The Subject's Global Assessment (SGA) of Satisfaction with Bowel Habit was used to measure this outcome. Patients were asked how satisfied they have been with their bowel habits in the previous week on a scale of 0 (Unsatisfied) to 100 (Very Satisfied).
arm group label: Senna
arm group type: Active Comparator
description: 1 capsule (50 mg) Senna daily for 12 weeks
arm group label: Linzess
arm group type: Active Comparator
description: 1 capsule (145 mcg) once daily for 12 weeks
intervention type: Drug
intervention name: Senna
description: 1 capsule (50 mg) Senna daily for 12 weeks
arm group label: Senna
other name: sennoside
intervention type: Drug
intervention name: Linzess
description: 1 capsule (145 mcg) of Linzess once daily for 12 weeks
arm group label: Linzess
other name: Linaclotide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Mohd A AlSamman, MD
role: Principal Investigator
affiliation: TriHealth Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Constipation
mesh term: Linaclotide
mesh term: Sennosides
sharing ipd: No
ipd description: Recruitment was low and therefore results are insufficient to share.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 