<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/NCT03806127</url>
  </required_header>
  <id_info>
    <org_study_id>URO-901-2001</org_study_id>
    <nct_id>NCT03806127</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome</brief_title>
  <official_title>A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Urovant Sciences GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Urovant Sciences GmbH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy and safety of vibegron, a beta-3 adrenergic receptor&#xD;
      (β3-AR) agonist, in the treatment of pain associated with irritable bowel syndrome (IBS) due&#xD;
      to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation&#xD;
      (IBS-M).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 31, 2018</start_date>
  <completion_date type="Actual">October 6, 2020</completion_date>
  <primary_completion_date type="Actual">September 25, 2020</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12</measure>
    <time_frame>Baseline; Week 12</time_frame>
    <description>An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of &quot;worst abdominal pain in the past 24 hours&quot; scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants</measure>
    <time_frame>Week 12</time_frame>
    <description>Global improvement assessment asks participants to evaluate their current IBS status by asking the following question: How would you rate your IBS signs or symptoms overall over the past 7 days?: (1) significantly relieved; (2) moderately relieved; (3) slightly relieved; (4) unchanged; (5) slightly worse; (6) moderately worse; (7) significantly worse. A responder was defined as a participant who answered that their symptoms were either moderately relieved or significantly relieved. A participant with a missing GIS response was considered to be a non-responder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks</measure>
    <time_frame>Baseline; 12 weeks</time_frame>
    <description>An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of &quot;worst abdominal pain in the past 24 hours&quot; scores of at least 40% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks</measure>
    <time_frame>Baseline; 12 weeks</time_frame>
    <description>An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of &quot;worst abdominal pain in the past 24 hours&quot; scores of at least 50% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Treatment-emergent Adverse Event (TEAE)</measure>
    <time_frame>from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Day 113 or Early Withdrawal plus 28 days)</time_frame>
    <description>TEAEs are defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12</measure>
    <time_frame>Baseline; Week 12</time_frame>
    <description>The investigator determined whether a change was clinically meaningful.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12</measure>
    <time_frame>Baseline; Week 12</time_frame>
    <description>Clinical relevance was determined by the investigator.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">222</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Vibegron 75 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive matching placebo orally once daily for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vibegron</intervention_name>
    <description>oral administration</description>
    <arm_group_label>Vibegron 75 mg</arm_group_label>
    <other_name>RVT-901</other_name>
    <other_name>MK-4618</other_name>
    <other_name>KRP-114V</other_name>
    <other_name>URO-901</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral administration</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of irritable bowel syndrome (IBS) with predominantly diarrhea (IBS-D) or IBS&#xD;
             with mixed episodes of diarrhea and constipation (IBS-M) according to the Rome IV&#xD;
             criteria&#xD;
&#xD;
          -  Has completed a colonoscopy according to the American Gastroenterological Association&#xD;
             criteria, with no clinically significant findings in the last 5 years&#xD;
&#xD;
          -  Has no clinically significant findings on a physical examination or clinical&#xD;
             laboratory tests that could interfere with study participation or confound study&#xD;
             assessments, in the opinion of the Investigator. Serum tissue transglutaminase&#xD;
             antibody (IgA) must be negative. Fecal calprotectin testing is optional and should&#xD;
             only be considered if there is a strong suspicion that the participant has&#xD;
             inflammatory bowel disease (IBD) (eg, family history in a 1st degree relative, other&#xD;
             genetic factors, etc.) or other organic disease, according to the clinical judgement&#xD;
             of the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of IBS-C or IBS-U per Rome IV criteria&#xD;
&#xD;
          -  History of chronic idiopathic constipation or functional constipation&#xD;
&#xD;
          -  Structural abnormality of the gastrointestinal tract or a disease (e.g., known small&#xD;
             intestine bacterial overgrowth) or condition that can affect gastrointestinal motility&#xD;
&#xD;
          -  History of a gastrointestinal motility disorder other than IBS (e.g., gastroparesis,&#xD;
             intestinal pseudo-obstruction, achalasia, Parkinsons disease, multiple sclerosis,&#xD;
             spinal cord injury)&#xD;
&#xD;
          -  Prior history of a gastrointestinal malignancy, inflammatory bowel disease, celiac&#xD;
             disease&#xD;
&#xD;
          -  Planned gastrointestinal or abdominal surgery within the next 6 months&#xD;
&#xD;
          -  Co-existing gastroesophageal reflux disease or functional dyspepsia with symptoms&#xD;
             predominant to IBS symptoms&#xD;
&#xD;
          -  Symptoms or diagnosis of a medical condition other than IBS that may contribute to&#xD;
             abdominal pain (e.g., interstitial cystitis; fibromyalgia currently being treated with&#xD;
             pregabalin or gabapentin; and endometriosis with uncontrolled abdominal pain)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.-Simon Williamson Clinic</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Associates</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alabama Medical Group, PC</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36693</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Research Institute</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GW Research Inc - ClinEdge-PPDS</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Triwest Research Associates, LLC</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Long Beach Healthcare System - NAVREF</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Research Institute Medical Group, Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desta Digestive Disease Medical Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Associates Research Group, Inc.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Clinical Research</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research Center of Connecticut LLC</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Division of Gastroenterology</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Center For Gastroenterology</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33777</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of Florida</name>
      <address>
        <city>Pompano Beach</city>
        <state>Florida</state>
        <zip>33060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Beach Research - ClinEdge - PPDS</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RNA America, LLC</name>
      <address>
        <city>Sugar Hill</city>
        <state>Georgia</state>
        <zip>30518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigators Research Group, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46268</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mandeville Private Physician Group, LLC</name>
      <address>
        <city>Mandeville</city>
        <state>Louisiana</state>
        <zip>70471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute of Michigan</name>
      <address>
        <city>Chesterfield</city>
        <state>Michigan</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Rita B. Chuang, MD, LLC</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atrium Healthcare Center for Digestive Health</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Digestive Diseases</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina Gastroenterology</name>
      <address>
        <city>Jacksonville</city>
        <state>North Carolina</state>
        <zip>28546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Gastroenterology, Inc.</name>
      <address>
        <city>Beavercreek</city>
        <state>Ohio</state>
        <zip>45440</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Sooner Research</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Anderson</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chattanooga Medical Research Inc</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Solutions PC</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DHAT Research Institute</name>
      <address>
        <city>Garland</city>
        <state>Texas</state>
        <zip>75044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.-Plano</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc. - Wasatch Peak Family Practice</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute</name>
      <address>
        <city>South Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <results_first_submitted>July 8, 2021</results_first_submitted>
  <results_first_submitted_qc>July 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 30, 2021</results_first_posted>
  <last_update_submitted>July 29, 2021</last_update_submitted>
  <last_update_submitted_qc>July 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Irritable Bowel Syndrome</keyword>
  <keyword>Irritable Bowel Syndrome with predominantly diarrhea (IBS-D)</keyword>
  <keyword>Irritable Bowel Syndrome with mixed episodes of diarrhea and constipation (IBS-M)</keyword>
  <keyword>Vibegron</keyword>
  <keyword>Beta-3 adrenergic receptor (β3-AR)</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03806127/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03806127/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of 806 participants screened for this study, 222 were randomized (after a 2-week, single-blind placebo Run-in Period), and 222 received 1 dose of double-blind study drug in the Treatment Period (Safety Set: placebo, N = 111; vibegron, N = 111).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).</description>
        </group>
        <group group_id="P2">
          <title>Vibegron 75 mg</title>
          <description>Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="111"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to Complete Procedures</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Could Not Come Due to Covid</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Prescribed Exclusionary Medication (Med)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ran Out of Study Meds (Covid Quarantine)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Covid 19 Restrictions</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawn Due to Work/School Schedule</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Covid 19 Concern; Possible Site Closure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline data are reported for all randomized participants who took at least one dose of double-blind study medication and had at least one evaluable post-randomization weekly abdominal pain intensity (API) score (i.e., where evaluable was considered a minimum of 5 diary entries in a week).</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).</description>
        </group>
        <group group_id="B2">
          <title>Vibegron 75 mg</title>
          <description>Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).</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="108"/>
            <count group_id="B2" value="111"/>
            <count group_id="B3" value="219"/>
          </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="39.6" spread="13.10"/>
                    <measurement group_id="B2" value="40.5" spread="13.88"/>
                    <measurement group_id="B3" value="40.1" spread="13.48"/>
                  </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="108"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="219"/>
                  </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>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Captured as Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <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>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <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>Abdominal Pain Intensity Score (Stratified Strata)</title>
          <description>Stratified strata was based on the randomization stratifications. Participants were asked to rate their IBS-related abdominal pain at its worst in the past 24 hours on a 0- to 10-point numeric rating scale, where 0 = no pain and 10 = the worst possible pain.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt; 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IBS Subtype (Stratified Strata)</title>
          <description>Stratified strata was based on the randomization stratifications. The Rome IV criteria classifies IBS into 4 distinct subtypes based on predominant stool consistency: IBS with predominantly constipation (IBS-C), IBS with predominantly diarrhea (IBS-D), IBS with mixed episodes of diarrhea and constipation (IBS-M), and IBS with unknown subtype (IBS-U). IBS-D: ≥ 25% diarrhea and &lt; 25% constipation. IBS-M: ≥ 25% constipation and ≥ 25% diarrhea.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>IBS-D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IBS-M</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12</title>
        <description>An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of &quot;worst abdominal pain in the past 24 hours&quot; scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).</description>
        <time_frame>Baseline; Week 12</time_frame>
        <population>Full Analysis Set for IBS-D participants: all randomized participants with IBS-D who who took at least one dose of double-blind study medication and had at least one evaluable post-randomization weekly API score (i.e., where evaluable was considered a minimum of 5 diary entries in a week)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).</description>
          </group>
          <group group_id="O2">
            <title>Vibegron 75 mg</title>
            <description>Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12</title>
          <description>An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of &quot;worst abdominal pain in the past 24 hours&quot; scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).</description>
          <population>Full Analysis Set for IBS-D participants: all randomized participants with IBS-D who who took at least one dose of double-blind study medication and had at least one evaluable post-randomization weekly API score (i.e., where evaluable was considered a minimum of 5 diary entries in a week)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="27"/>
                  </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>Other</non_inferiority_type>
            <param_type>Cochran-Mantel-Haenszel (CMH) Difference</param_type>
            <param_value>-1.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.1</ci_lower_limit>
            <ci_upper_limit>12.3</ci_upper_limit>
            <estimate_desc>Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (&lt; 6 versus ≥ 6) strata, with weights proposed by Greenland and Robins.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants</title>
        <description>Global improvement assessment asks participants to evaluate their current IBS status by asking the following question: How would you rate your IBS signs or symptoms overall over the past 7 days?: (1) significantly relieved; (2) moderately relieved; (3) slightly relieved; (4) unchanged; (5) slightly worse; (6) moderately worse; (7) significantly worse. A responder was defined as a participant who answered that their symptoms were either moderately relieved or significantly relieved. A participant with a missing GIS response was considered to be a non-responder.</description>
        <time_frame>Week 12</time_frame>
        <population>Full Analysis Set: all randomized participants who took at least one dose of double-blind study medication and had at least one evaluable post-randomization weekly API score (i.e., where evaluable was considered a minimum of 5 diary entries in a week)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).</description>
          </group>
          <group group_id="O2">
            <title>Vibegron 75 mg</title>
            <description>Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants</title>
          <description>Global improvement assessment asks participants to evaluate their current IBS status by asking the following question: How would you rate your IBS signs or symptoms overall over the past 7 days?: (1) significantly relieved; (2) moderately relieved; (3) slightly relieved; (4) unchanged; (5) slightly worse; (6) moderately worse; (7) significantly worse. A responder was defined as a participant who answered that their symptoms were either moderately relieved or significantly relieved. A participant with a missing GIS response was considered to be a non-responder.</description>
          <population>Full Analysis Set: all randomized participants who took at least one dose of double-blind study medication and had at least one evaluable post-randomization weekly API score (i.e., where evaluable was considered a minimum of 5 diary entries in a week)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IBS-D Participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IBS-M Participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All Participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="44"/>
                  </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>
            <groups_desc>IBS-D Participants</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>CMH Difference</param_type>
            <param_value>9.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.8</ci_lower_limit>
            <ci_upper_limit>22.9</ci_upper_limit>
            <estimate_desc>Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (&lt; 6 versus &gt;= 6) strata, with weights proposed by Greenland and Robins.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>IBS-M Participants</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>CMH Difference</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.7</ci_lower_limit>
            <ci_upper_limit>16.4</ci_upper_limit>
            <estimate_desc>Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (&lt; 6 versus &gt;= 6) strata, with weights proposed by Greenland and Robins.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>All Participants</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>CMH Difference</param_type>
            <param_value>5.3</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.4</ci_lower_limit>
            <ci_upper_limit>15.9</ci_upper_limit>
            <estimate_desc>Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (&lt; 6 versus &gt;= 6) strata, with weights proposed by Greenland and Robins.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks</title>
        <description>An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of &quot;worst abdominal pain in the past 24 hours&quot; scores of at least 40% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).</description>
        <time_frame>Baseline; 12 weeks</time_frame>
        <population>Full Analysis Set for IBS-D participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).</description>
          </group>
          <group group_id="O2">
            <title>Vibegron 75 mg</title>
            <description>Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks</title>
          <description>An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of &quot;worst abdominal pain in the past 24 hours&quot; scores of at least 40% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).</description>
          <population>Full Analysis Set for IBS-D participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="22"/>
                  </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>Other</non_inferiority_type>
            <param_type>CMH Difference</param_type>
            <param_value>1.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.7</ci_lower_limit>
            <ci_upper_limit>14.9</ci_upper_limit>
            <estimate_desc>Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (&lt; 6 versus &gt;= 6) strata, with weights proposed by Greenland and Robins.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks</title>
        <description>An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of &quot;worst abdominal pain in the past 24 hours&quot; scores of at least 50% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).</description>
        <time_frame>Baseline; 12 weeks</time_frame>
        <population>Full Analysis Set for IBS-D participants</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).</description>
          </group>
          <group group_id="O2">
            <title>Vibegron 75 mg</title>
            <description>Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks</title>
          <description>An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of &quot;worst abdominal pain in the past 24 hours&quot; scores of at least 50% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).</description>
          <population>Full Analysis Set for IBS-D participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="18"/>
                  </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>Other</non_inferiority_type>
            <param_type>CMH Difference</param_type>
            <param_value>6.7</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.5</ci_lower_limit>
            <ci_upper_limit>18.8</ci_upper_limit>
            <estimate_desc>Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (&lt; 6 versus ≥ 6) strata, with weights proposed by Greenland and Robins.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Treatment-emergent Adverse Event (TEAE)</title>
        <description>TEAEs are defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment.</description>
        <time_frame>from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Day 113 or Early Withdrawal plus 28 days)</time_frame>
        <population>Safety Analysis Set: all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).</description>
          </group>
          <group group_id="O2">
            <title>Vibegron 75 mg</title>
            <description>Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Treatment-emergent Adverse Event (TEAE)</title>
          <description>TEAEs are defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment.</description>
          <population>Safety Analysis Set: all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12</title>
        <description>The investigator determined whether a change was clinically meaningful.</description>
        <time_frame>Baseline; Week 12</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).</description>
          </group>
          <group group_id="O2">
            <title>Vibegron 75 mg</title>
            <description>Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12</title>
          <description>The investigator determined whether a change was clinically meaningful.</description>
          <population>Safety Analysis Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12</title>
        <description>Clinical relevance was determined by the investigator.</description>
        <time_frame>Baseline; Week 12</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).</description>
          </group>
          <group group_id="O2">
            <title>Vibegron 75 mg</title>
            <description>Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12</title>
          <description>Clinical relevance was determined by the investigator.</description>
          <population>Safety Analysis Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)</time_frame>
      <desc>Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]).</description>
        </group>
        <group group_id="E2">
          <title>Vibegron 75 mg</title>
          <description>Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (&lt; 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDra 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Ectopic pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDra 23.1</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="19" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteriuria</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocyturia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
              </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>The Sponsor does not object to publication by Institution or Principal Investigator (PI) of results of the Trial based on information collected or generated by the Institution or PI. However, the Institution and PI are required to provide the Sponsor with an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed to ensure against any inadvertent disclosure of Sponsor Confidential Information or unprotected Sponsor Inventions.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Information, Clinical Trial Results</name_or_title>
      <organization>Urovant Sciences</organization>
      <phone>949-226-6029</phone>
      <email>info@urovant.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/NCT03806127
org study id: URO-901-2001
nct id: NCT03806127
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the efficacy and safety of vibegron, a beta-3 adrenergic receptor
      (β3-AR) agonist, in the treatment of pain associated with irritable bowel syndrome (IBS) due
      to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation
      (IBS-M).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12
time frame: Baseline; Week 12
description: An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
measure: Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants
time frame: Week 12
description: Global improvement assessment asks participants to evaluate their current IBS status by asking the following question: How would you rate your IBS signs or symptoms overall over the past 7 days?: (1) significantly relieved; (2) moderately relieved; (3) slightly relieved; (4) unchanged; (5) slightly worse; (6) moderately worse; (7) significantly worse. A responder was defined as a participant who answered that their symptoms were either moderately relieved or significantly relieved. A participant with a missing GIS response was considered to be a non-responder.
measure: Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks
time frame: Baseline; 12 weeks
description: An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 40% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
measure: Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks
time frame: Baseline; 12 weeks
description: An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 50% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
time frame: from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Day 113 or Early Withdrawal plus 28 days)
description: TEAEs are defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment.
measure: Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12
time frame: Baseline; Week 12
description: The investigator determined whether a change was clinically meaningful.
measure: Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12
time frame: Baseline; Week 12
description: Clinical relevance was determined by the investigator.
arm group label: Vibegron 75 mg
arm group type: Experimental
description: Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive matching placebo orally once daily for 12 weeks.
intervention type: Drug
intervention name: Vibegron
description: oral administration
arm group label: Vibegron 75 mg
other name: RVT-901
other name: MK-4618
other name: KRP-114V
other name: URO-901
intervention type: Drug
intervention name: Placebo
description: oral administration
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
sharing ipd: No
provided document: 
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reported events: 
certain agreements: 
point of contact: 