xml: <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/NCT06024642</url>
    </required_header>
    <id_info>
      <org_study_id>OAG1030</org_study_id>
      <nct_id>NCT06024642</nct_id>
    </id_info>
    <brief_title>Study of V117957 in Overactive Bladder Syndrome</brief_title>
    <official_title>Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Overactive Bladder Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imbrium Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Purdue Pharma LP</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Imbrium Therapeutics</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in&#xD;
        subjects with overactive bladder syndrome, compared to placebo.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 30, 2022</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in number of micturition episodes per 24 hours and number of incontinence episodes per 24 hours.</measure>
      <time_frame>Baseline, Weeks 2, 4, 6, 8, and 9</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline in volume voided per 24 hours.</measure>
      <time_frame>Baseline, Weeks 2, 4, 6, 8, and 9</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Patient Perception of Bladder Condition (PPBC)</measure>
      <time_frame>Baseline, Weeks 2, 4, 6, 8, and 9</time_frame>
      <description>The PPBC is a single item that assesses the patients' subjective impression of their current urinary problem.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Overactive Bladder Questionnaire: Long-Form, 1-week Recall (OAB-q LF)</measure>
      <time_frame>Baseline, Weeks 2, 4, 6, 8, and 9</time_frame>
      <description>The OAB-q LF is a 33-item, condition-specific measure designed to assess the impact of OAB symptoms on Health-related Quality of Life (HRQL).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Subject Global Response Assessment (SGRA)</measure>
      <time_frame>Baseline, Weeks 2, 4, 6, 8, and 9</time_frame>
      <description>The SGRA is a self-rated balanced measure of subject's clinical condition relative to baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS)</measure>
      <time_frame>Baseline, Weeks 2, 4, 6, 8, and 9</time_frame>
      <description>The PPIUS is a 5-point scale designed for measurement of both urinary urgency and urge incontinence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Symptom Impact Sleep Questionnaire (SISQ)</measure>
      <time_frame>Baseline, Weeks 2, 4, 6, 8, and 9</time_frame>
      <description>The SISQ contains 2 questions that assess the quality of sleep and the impact of the subject's symptoms of OAB on sleep.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Overactive Bladder Syndrome</condition>
    <arm_group>
      <arm_group_label>V117957</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>V117957</intervention_name>
      <description>V117957 1 mg - 1 tablet taken orally at bedtime.</description>
      <arm_group_label>V117957</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria include:&#xD;
  &#xD;
            1. Female, age ≥18-64 years and capable of voiding independently. Able to comply with&#xD;
               acceptable methods of contraception.&#xD;
  &#xD;
            2. Has symptoms of overactive bladder including (OAB) urinary urgency and urinary&#xD;
               frequency with incontinence for ≥3 months.&#xD;
  &#xD;
            3. Willing to modify current OAB treatment regimen.&#xD;
  &#xD;
          Key Exclusion Criteria include:&#xD;
  &#xD;
            1. Significant stress incontinence or mixed stress/urge incontinence where stress is the&#xD;
               predominant factor.&#xD;
  &#xD;
            2. Urinary tract infection (UTI) within past 30 days, or history of recurrent UTI.&#xD;
  &#xD;
            3. Hematuria associated with bladder malignancy or other significant pathology.&#xD;
  &#xD;
            4. Had surgical procedure that affected bladder function.&#xD;
  &#xD;
            5. Received intravesical therapy within past 12 months or had bladder hydrodistention&#xD;
               within past 6 months.&#xD;
  &#xD;
            6. Grade III/IV pelvic organ prolapse with/without cystocele or urethral diverticulum.&#xD;
  &#xD;
            7. Clinically significant kidney disease or nephrolithiasis.&#xD;
  &#xD;
          Other protocol-specific inclusion and exclusion criteria may apply.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Medical Services</last_name>
      <phone>1-888-726-7535</phone>
      <email>Purduemedinfo@pharma.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bay State Clinical Trials, Inc.</name>
        <address>
          <city>Watertown</city>
          <state>Massachusetts</state>
          <zip>02472</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Central Contact</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Bladder, Overactive</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024642
  org study id: OAG1030
  nct id: NCT06024642
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in
        subjects with overactive bladder syndrome, compared to placebo.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Change from baseline in number of micturition episodes per 24 hours and number of incontinence episodes per 24 hours.
  time frame: Baseline, Weeks 2, 4, 6, 8, and 9
  measure: Change from baseline in volume voided per 24 hours.
  time frame: Baseline, Weeks 2, 4, 6, 8, and 9
  measure: Change from baseline in Patient Perception of Bladder Condition (PPBC)
  time frame: Baseline, Weeks 2, 4, 6, 8, and 9
  description: The PPBC is a single item that assesses the patients' subjective impression of their current urinary problem.
  measure: Change from baseline in Overactive Bladder Questionnaire: Long-Form, 1-week Recall (OAB-q LF)
  time frame: Baseline, Weeks 2, 4, 6, 8, and 9
  description: The OAB-q LF is a 33-item, condition-specific measure designed to assess the impact of OAB symptoms on Health-related Quality of Life (HRQL).
  measure: Change from baseline in Subject Global Response Assessment (SGRA)
  time frame: Baseline, Weeks 2, 4, 6, 8, and 9
  description: The SGRA is a self-rated balanced measure of subject's clinical condition relative to baseline.
  measure: Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS)
  time frame: Baseline, Weeks 2, 4, 6, 8, and 9
  description: The PPIUS is a 5-point scale designed for measurement of both urinary urgency and urge incontinence.
  measure: Change from baseline in Symptom Impact Sleep Questionnaire (SISQ)
  time frame: Baseline, Weeks 2, 4, 6, 8, and 9
  description: The SISQ contains 2 questions that assess the quality of sleep and the impact of the subject's symptoms of OAB on sleep.
  arm group label: V117957
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: V117957
  description: V117957 1 mg - 1 tablet taken orally at bedtime.
  arm group label: V117957
  intervention type: Drug
  intervention name: Placebo
  description: Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.
  arm group label: Placebo
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Medical Services
  phone: 1-888-726-7535
  email: Purduemedinfo@pharma.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Urinary Bladder, Overactive
  mesh term: Syndrome