<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/NCT04486326</url>
  </required_header>
  <id_info>
    <org_study_id>2020P-000464</org_study_id>
    <nct_id>NCT04486326</nct_id>
  </id_info>
  <brief_title>Crofelemer for Functional Diarrhea</brief_title>
  <official_title>Crofelemer for Functional Diarrhea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this study are to evaluate the clinical response of patients with&#xD;
      diarrhea to crofelemer relative to placebo and evaluate the overall safety and tolerability&#xD;
      of crofelemer in the treatment of diarrhea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">August 20, 2020</start_date>
  <completion_date type="Actual">September 23, 2022</completion_date>
  <primary_completion_date type="Actual">September 23, 2022</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bristol Stool Form Scale</measure>
    <time_frame>week 8</time_frame>
    <description>measures stool consistency by type from 1-7</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Diarrhea</condition>
  <arm_group>
    <arm_group_label>crofelemer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>125mg bid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>bid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Crofelemer</intervention_name>
    <description>Crofelemer</description>
    <arm_group_label>crofelemer</arm_group_label>
    <other_name>mytesi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is a man or woman aged 18 to 65 years, inclusive, at Screening.&#xD;
&#xD;
          2. Patient has functional diarrhea defined by the Rome IV criteria as loose (mushy) or&#xD;
             watery stools ≥25% and hard or lumpy stools &lt;25% of bowel movements&#xD;
&#xD;
          3. Patient has had a colonoscopy performed:&#xD;
&#xD;
               1. Within 10 years prior to Prescreening if patient is at least 50 years of age&#xD;
                  (alternatively, a flexible sigmoidoscopy, double contrast barium enema, or CT&#xD;
                  colonography within the past 5 years is acceptable [see recommendations of the&#xD;
                  American Cancer Society])&#xD;
&#xD;
               2. Since the onset (if applicable) of any of the following alarm features for&#xD;
                  patients of any age (see Spiller and Thompson, 2010 - i.e. Patient has documented&#xD;
                  weight loss within the past 6 months; Patient has nocturnal symptoms; Patient has&#xD;
                  a familial history of colon cancer; or patient has blood mixed with their stool&#xD;
                  (excluding any blood from hemorrhoids).&#xD;
&#xD;
          4. Patient has an average daily stool consistency score (BSS) of ≥5.5 on days without the&#xD;
             use of an anti-diarrheal and at least 3 days with a BSS score ≥5 on a 1 to 7 scale&#xD;
             over the week prior to randomization.&#xD;
&#xD;
          5. Patient has completed the daily diary on at least 6 of the 7 days during the week&#xD;
             prior to randomization AND at least 11 of the 14 days during the 2 weeks prior to&#xD;
             randomization.&#xD;
&#xD;
          6. Patient has not used loperamide rescue medication more than 4 days during the&#xD;
             screening period.&#xD;
&#xD;
          7. Patient is not planning to change his/her usual diet and lifestyle during the course&#xD;
             of the study.&#xD;
&#xD;
          8. Patient is willing to be compliant with study procedures including completing the&#xD;
             daily diary during the screening period and throughout the study.&#xD;
&#xD;
          9. Patient must sign an informed consent document before the initiation of any&#xD;
             study-related procedures indicating that he or she understands the purpose of and&#xD;
             procedures required for the study and is willing to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has a history of inflammatory or immune-mediated GI disorders including&#xD;
             inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis, microscopic&#xD;
             colitis) and celiac disease.&#xD;
&#xD;
          2. Patient has a predominant symptom of abdominal pain.&#xD;
&#xD;
          3. Patient has a history of diverticulitis within 3 months prior to screening. Patients&#xD;
             with a history of diverticulosis are candidates for the study.&#xD;
&#xD;
          4. Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI&#xD;
             perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic&#xD;
             colitis, or impaired intestinal circulation (eg, aortoiliac disease).&#xD;
&#xD;
          5. Patient has any of the following surgical history:&#xD;
&#xD;
               1. Any abdominal surgery within the 3 months prior to screening; or&#xD;
&#xD;
               2. Patient has a history of major gastric, hepatic, pancreatic, or intestinal&#xD;
                  surgery (appendectomy, cholecystectomy, hemorrhoidectomy, or polypectomy greater&#xD;
                  than 3 months are allowed). For the purposes of this study, laparoscopic&#xD;
                  surgeries without complication are considered minor and non-exclusionary,&#xD;
                  provided the condition for which the surgery was performed was not exclusionary.&#xD;
&#xD;
          6. Patient has an unstable renal, hepatic, metabolic, or hematologic condition.&#xD;
&#xD;
          7. Patient has a history of human immunodeficiency virus infection.&#xD;
&#xD;
          8. Patient has a history of DSM-IV-TR-defined substance dependency, excluding nicotine&#xD;
             and caffeine, within 2 years prior to Prescreening.&#xD;
&#xD;
          9. Patient has a history of alcohol abuse as defined by DSM-IV-TR, binge drinking as&#xD;
             defined by the National Institutes on Alcohol Abuse and Alcoholism, or any medical&#xD;
             treatment for alcohol-related co-morbidities, within 5 years prior to Prescreening.&#xD;
             Recovered alcoholics who have not consumed alcohol over the 5 years prior to&#xD;
             Prescreening are candidates for the study.&#xD;
&#xD;
         10. Patient has current (within 14 days of randomization) or expected use of any narcotic&#xD;
             or opioid containing agents, tramadol&#xD;
&#xD;
         11. Patient is unable to swallow solid, oral dosage forms whole with the aid of liquid&#xD;
             (patients may not chew, divide, dissolve, or crush the study drug).&#xD;
&#xD;
         12. Patient has received an investigational drug or used an investigational medical device&#xD;
             within 30 days prior to randomization.&#xD;
&#xD;
         13. Patient has a known pregnancy or is breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Lembo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Anthony Lembo</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04486326
org study id: 2020P-000464
nct id: NCT04486326
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The primary objectives of this study are to evaluate the clinical response of patients with
      diarrhea to crofelemer relative to placebo and evaluate the overall safety and tolerability
      of crofelemer in the treatment of diarrhea.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Bristol Stool Form Scale
time frame: week 8
description: measures stool consistency by type from 1-7
arm group label: crofelemer
arm group type: Experimental
description: 125mg bid
arm group label: placebo
arm group type: Placebo Comparator
description: bid
intervention type: Drug
intervention name: Crofelemer
description: Crofelemer
arm group label: crofelemer
other name: mytesi
intervention type: Drug
intervention name: Placebo
description: placebo
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Anthony Lembo, MD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Anthony Lembo
investigator title: Professor of Medicine
mesh term: Diarrhea
sharing ipd: No