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/NCT05976802</url>
    </required_header>
    <id_info>
      <org_study_id>BFUC4991</org_study_id>
      <nct_id>NCT05976802</nct_id>
    </id_info>
    <brief_title>Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis</brief_title>
    <official_title>A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam BID for 2 Weeks, Followed by QD for 4 Weeks, in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bausch Health Americas, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bausch Health Americas, Inc.</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 primary objective of this study is to evaluate the efficacy (as measured by induction of&#xD;
        remission) of two dose levels (low and high) per age group (5 to &lt;12 and 12 to ≤17 years) of&#xD;
        budesonide rectal foam as compared to an equivalent volume of rectally administered placebo&#xD;
        foam over the same dosing schedule, in pediatric subjects with active, mild to moderate&#xD;
        distal ulcerative colitis (UC).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">June 2024</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of participants with clinical remission</measure>
      <time_frame>Day 42</time_frame>
      <description>Clinical remission based on the modified Mayo Clinic Score, defined as an endoscopy score ≤ 1 (excluding friability), a rectal bleeding subscore of 0, and at least a 1-point decrease in stool frequency subscore from Baseline to achieve a stool frequency subscore ≤ 1. Each component is scored from 0 to 3, with total scores ranging from 0 to 9, with higher scores indicating more severe disease.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants who achieve a rectal bleeding subscale score of 0 at the end of six weeks of treatment</measure>
      <time_frame>Day 42</time_frame>
      <description>Scored from 0 to 3, with higher scores indicating more severe disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants who achieve a stool frequency subscale score of 0 at the end of six weeks of treatment.</measure>
      <time_frame>Day 42</time_frame>
      <description>Scored from 0 to 3, with higher scores indicating more severe disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects who achieve an endoscopy subscale score of 0 or 1 at the end of six weeks of treatment.</measure>
      <time_frame>Day 42</time_frame>
      <description>Scored from 0 to 3, with higher scores indicating more severe disease.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Ulcerative Colitis</condition>
    <arm_group>
      <arm_group_label>High dose budesonide rectal foam</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Low dose budesonide rectal foam</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Matching placebo rectal foam</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>High dose budesonide rectal foam</intervention_name>
      <description>Twice a day for 2 weeks, then once a day for 4 weeks</description>
      <arm_group_label>High dose budesonide rectal foam</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Low dose budesonide rectal foam</intervention_name>
      <description>Twice a day for 2 weeks, then once a day for 4 weeks</description>
      <arm_group_label>Low dose budesonide rectal foam</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Matching placebo rectal foam</intervention_name>
      <description>Twice a day for 2 weeks, then once a day for 4 weeks</description>
      <arm_group_label>Matching placebo rectal foam</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male and Female (non-pregnant and non-lactating) 5 to ≤17 years of age at Screening.&#xD;
  &#xD;
            2. Established diagnosis of UC, based on clinical history, characteristic endoscopic&#xD;
               findings, and histopathology results from biopsies.&#xD;
  &#xD;
            3. Disease limited to the distal colon and rectum, (disease involving only the first 15&#xD;
               centimeters or less proximal to the anal verge).&#xD;
  &#xD;
            4. Active, distal UC of mild or moderate severity, defined as a Modified Mayo Clinic&#xD;
               Score (mMCS) between 4 and 8, inclusive, that includes an endoscopy subscore ≥ 2 and a&#xD;
               rectal bleeding subscore ≥ 1.&#xD;
  &#xD;
            5. If on a background oral 5-ASA, the dose and formulation have remained unchanged for at&#xD;
               least 6 weeks prior to Visit 2 (Run-In) and the subject is willing to remain on the&#xD;
               same dosage form and regimen for the duration of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Current or prior diagnosis of Crohn's disease or indeterminate colitis.&#xD;
  &#xD;
            2. Ulcerative colitis involving the proximal colon - i.e, the sigmoid, left, transverse,&#xD;
               and/or ascending colon and cecum;&#xD;
  &#xD;
            3. Severe UC, defined as an mMCS &gt; 8.&#xD;
  &#xD;
            4. Infectious colitis (based on positive microbiologic tests at Screening) or any recent&#xD;
               history of infectious colitis (within 30 days of Screening).&#xD;
  &#xD;
            5. Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal,&#xD;
               umbilical).&#xD;
  &#xD;
               NOTE: Prior cholecystectomy is not exclusionary if more than 1 year prior to&#xD;
               Screening.&#xD;
  &#xD;
            6. Evidence or history of toxic megacolon or bowel resection.&#xD;
  &#xD;
            7. Active proctologic pathology such as hemorrhoids, fistulas and fissures or other&#xD;
               historical anatomic problems which would impair rectal administration (e.g., cloaca,&#xD;
               imperforate anus history)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Varsha Bhatt</last_name>
      <role>Study Director</role>
      <affiliation>Bausch Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Varsha Bhatt</last_name>
      <phone>707-285-1528</phone>
      <email>Varsha.Bhatt@bauschhealth.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 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>Colitis</mesh_term>
      <mesh_term>Colitis, Ulcerative</mesh_term>
      <mesh_term>Ulcer</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Budesonide</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05976802
  org study id: BFUC4991
  nct id: NCT05976802
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary objective of this study is to evaluate the efficacy (as measured by induction of
        remission) of two dose levels (low and high) per age group (5 to <12 and 12 to ≤17 years) of
        budesonide rectal foam as compared to an equivalent volume of rectally administered placebo
        foam over the same dosing schedule, in pediatric subjects with active, mild to moderate
        distal ulcerative colitis (UC).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Proportion of participants with clinical remission
  time frame: Day 42
  description: Clinical remission based on the modified Mayo Clinic Score, defined as an endoscopy score ≤ 1 (excluding friability), a rectal bleeding subscore of 0, and at least a 1-point decrease in stool frequency subscore from Baseline to achieve a stool frequency subscore ≤ 1. Each component is scored from 0 to 3, with total scores ranging from 0 to 9, with higher scores indicating more severe disease.
  measure: Proportion of participants who achieve a rectal bleeding subscale score of 0 at the end of six weeks of treatment
  time frame: Day 42
  description: Scored from 0 to 3, with higher scores indicating more severe disease.
  measure: Proportion of participants who achieve a stool frequency subscale score of 0 at the end of six weeks of treatment.
  time frame: Day 42
  description: Scored from 0 to 3, with higher scores indicating more severe disease.
  measure: Proportion of subjects who achieve an endoscopy subscale score of 0 or 1 at the end of six weeks of treatment.
  time frame: Day 42
  description: Scored from 0 to 3, with higher scores indicating more severe disease.
  arm group label: High dose budesonide rectal foam
  arm group type: Experimental
  arm group label: Low dose budesonide rectal foam
  arm group type: Experimental
  arm group label: Matching placebo rectal foam
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: High dose budesonide rectal foam
  description: Twice a day for 2 weeks, then once a day for 4 weeks
  arm group label: High dose budesonide rectal foam
  intervention type: Drug
  intervention name: Low dose budesonide rectal foam
  description: Twice a day for 2 weeks, then once a day for 4 weeks
  arm group label: Low dose budesonide rectal foam
  intervention type: Drug
  intervention name: Matching placebo rectal foam
  description: Twice a day for 2 weeks, then once a day for 4 weeks
  arm group label: Matching placebo rectal foam
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Varsha Bhatt
  role: Study Director
  affiliation: Bausch Health
  last name: Varsha Bhatt
  phone: 707-285-1528
  email: Varsha.Bhatt@bauschhealth.com
  responsible party type: Sponsor
  mesh term: Colitis
  mesh term: Colitis, Ulcerative
  mesh term: Ulcer
  mesh term: Budesonide
  sharing ipd: Undecided