<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/NCT04469686</url>
  </required_header>
  <id_info>
    <org_study_id>CHS1221</org_study_id>
    <secondary_id>2019-003596-19</secondary_id>
    <nct_id>NCT04469686</nct_id>
  </id_info>
  <brief_title>Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories</brief_title>
  <official_title>3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cristcot LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cristcot HCA LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cristcot LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, multi-center, double-blind, three arm placebo-controlled study in male and&#xD;
      non-pregnant, non-lactating female subjects aged 18 years to examine the safety and efficacy&#xD;
      of two dosing regimens of hydrocortisone acetate 90 mg suppository administered with the&#xD;
      Sephure applicator for the treatment of ulcerative colitis of the rectum.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hydrocortisone acetate 90 mg or placebo will be administered as a rectal suppository with a&#xD;
      Sephure suppository applicator. Two arms of the study will receive different dosage regimens&#xD;
      of hydrocortisone acetate, and the third arm will receive placebo. All subjects will&#xD;
      administer the study drug twice a day; once in the morning and once in the evening for 28&#xD;
      days.&#xD;
&#xD;
      The study population will consist of male and non pregnant, non lactating females aged 18&#xD;
      years and older with a confirmed diagnosis of active UC of the rectum.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 10, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical remission measured using the Modified Mayo Score</measure>
    <time_frame>28 days</time_frame>
    <description>To evaluate the the efficacy of two dosage regimens of the study drug</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency</measure>
    <time_frame>28 days</time_frame>
    <description>To assess the change in stool frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0</measure>
    <time_frame>28 days</time_frame>
    <description>To assess the change in rectal bleeding</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of Life assessed measured using IBDQ validated questionnaire</measure>
    <time_frame>28 days</time_frame>
    <description>To examine the quality of life of patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Grading of disease severity measure using Mayo Scoring sub-score of Physician's Global Assessment</measure>
    <time_frame>28 days</time_frame>
    <description>To assess disease severity</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentrations of hydrocortisone acetate using pharmacokinetic sampling</measure>
    <time_frame>28 days</time_frame>
    <description>To evaluate the exposure of hydrocortisone acetate levels for safety</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">618</enrollment>
  <condition>Ulcerative Proctitis</condition>
  <arm_group>
    <arm_group_label>Twice Daily - Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Once Daily - Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Twice daily placebo suppository administered with Sephure suppository applicator</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator</intervention_name>
    <description>Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator</description>
    <arm_group_label>Twice Daily - Active</arm_group_label>
    <other_name>Twice Daily - Active</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator</intervention_name>
    <description>Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator</description>
    <arm_group_label>Once Daily - Active</arm_group_label>
    <other_name>Once Daily - Active</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Twice daily placebo suppository administered with Sephure applicator</intervention_name>
    <description>Twice daily placebo suppository administered with Sephure applicator</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Twice Daily - Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or non pregnant, non lactating females aged 18 years and older.&#xD;
&#xD;
          -  Subjects with a confirmed diagnosis of active UC of the rectum, extending no more than&#xD;
             15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy&#xD;
             performed at Visit 2. Note: Subjects may have a history of more extensive UC (e.g.,&#xD;
             pancolitis), but have active disease only in the rectum at the time of enrollment.&#xD;
&#xD;
          -  Modified Mayo sub score for stool frequency of 1 3.&#xD;
&#xD;
          -  Modified Mayo sub score for rectal bleeding of 0 2.&#xD;
&#xD;
          -  Modified Mayo endoscopic sub score of 2 3.&#xD;
&#xD;
          -  Total Modified Mayo Score (without physician global assessment) of 4-8.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or current diagnosis of bacterial or other infectious colitis, radiation&#xD;
             enteritis and radiation proctitis, Crohn's disease, collagenous colitis and&#xD;
             indeterminate colitis.&#xD;
&#xD;
          -  Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia.&#xD;
&#xD;
          -  Concomitant active lower gastrointestinal disease (except Irritable Bowel Syndrome) or&#xD;
             distortion of intestinal anatomy.&#xD;
&#xD;
          -  Bleeding hemorrhoids at the time of enrollment.&#xD;
&#xD;
          -  Acute diverticulitis at the time of enrollment.&#xD;
&#xD;
          -  Acute or chronic pancreatitis at the time of enrollment.&#xD;
&#xD;
          -  Unmanaged celiac disease at the time of enrollment.&#xD;
&#xD;
          -  Positive stool test for enteric pathogens, Clostridium difficile, or presence of ova&#xD;
             and parasites.&#xD;
&#xD;
          -  Taking a prohibited medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karthik Devarajan, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cristcot LLC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mark C Ensign</last_name>
    <phone>978-212-6380</phone>
    <email>mark.ensign@cristcot.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lead Scientist</last_name>
    <phone>978-212-6380</phone>
    <email>research@cessa-uc.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinical Research Associates LLC</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peg Rochina</last_name>
      <phone>256-536-6600</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Om Research</name>
      <address>
        <city>Apple Valley</city>
        <state>California</state>
        <zip>92307</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Neera Grover</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Om Research</name>
      <address>
        <city>Camarillo</city>
        <state>California</state>
        <zip>93012</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen Simon</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Om Research</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jatinder Pruthi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Precision Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92020</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlton Thomas</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Applications Laboratories</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vijaya Pratha</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Homestead Associates in Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kenia Atienzo</last_name>
    </contact>
    <contact_backup>
      <last_name>Jhenny Grullon</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Rejuvaline Medical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yunaiky Rivera</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>US Associates in Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gilberto Seco</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>GI PROs Research</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raymond Phillips</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Revival Clinical Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32807</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seela Ramesh</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>International Center for Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angel Rosario</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>One Health Research Clinic Atlanta</name>
      <address>
        <city>Norcross</city>
        <state>Georgia</state>
        <zip>30093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sylvia Fischer</last_name>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Karie Simons</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Revive Research Institute</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Obianuju Lindia Ogbonna</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Research of Michigan</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Partha Nandi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sanmora Bespoke Clinical Research</name>
      <address>
        <city>East Orange</city>
        <state>New Jersey</state>
        <zip>07018</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adigun Rotimi</last_name>
      <phone>973-676-1920</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ohio Gastroenterology &amp; Liver Institute</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pradeep K Bekal</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Great Lakes Gastroenterology Research, LLC</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brooke Adamic, SN</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr. Mouhamed Al-Sabbagh</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77043</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mouhamed Al-Sabbagh</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Southern Star Research Institute</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Garza Mireya</last_name>
      <phone>210-581-2812</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Texas Gastroenterology Associates (A1 Clinical)</name>
      <address>
        <city>Spring</city>
        <state>Texas</state>
        <zip>77386</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Schumyla Iftykhar</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan Fallingborg</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hvidovre Hospital</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ida Vind</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zealand University Hospital</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marianne Vester-Anderson</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Studiengesellschaft BSF UG</name>
      <address>
        <city>Halle</city>
        <zip>06108</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karolina Winkler</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>EuGastro GmbH</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yvonne Maybaum</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>ICON Hospital</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380015</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manish Bhatnagar</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ashwin Medical Foundation Multispeciality Hospital</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411033</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aditi Wad</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Acharya Vinoba Bhave Rural Hospital</name>
      <address>
        <city>Wardha</city>
        <state>Maharashtra</state>
        <zip>442004</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Priyanka Kawale</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Max Smart Super Speciality Hospital</name>
      <address>
        <city>Saket</city>
        <state>New Delhi</state>
        <zip>100017</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jyoti Dhiman</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>SMS Medical College &amp; Hospital</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302004</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rakesh Saini</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>SIMS Hospital</name>
      <address>
        <city>Chennai</city>
        <state>Tamilnadu</state>
        <zip>600026</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manisha M</last_name>
    </contact>
    <contact_backup>
      <last_name>Srinivas Vedantha</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Ospedale: Azienda Policlinico Universitario Bari</name>
      <address>
        <city>Bari</city>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valeria Suriano, MS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Università di Cagliari, Dipartimento di Scienze mediche e sanità pubblica</name>
      <address>
        <city>Cagliari</city>
        <zip>09042</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sergio Pinto</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University della Campania 'Luigi Vanvitelli'</name>
      <address>
        <city>Napoli</city>
        <zip>80138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Agnese Miranda, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Lucia Granata, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hospital da Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Greta Lorenzon</last_name>
    </contact>
    <contact_backup>
      <last_name>Alessandra Rigo</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>A.O. Ordine Mauriziano di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cristina Guiotto</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cebu Doctors' University Hospital</name>
      <address>
        <city>Cebu City</city>
        <state>Cebu</state>
        <zip>6000</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Louisse Noelle Prile</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Medical City Iloilo</name>
      <address>
        <city>Iloilo City</city>
        <state>Iloilo</state>
        <zip>5000</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Webster Padernal</last_name>
    </contact>
    <contact_backup>
      <last_name>Bea Nestie Angeli Villareal</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>West Visayas State University Medical Center</name>
      <address>
        <city>Iloilo City</city>
        <state>Iloilo</state>
        <zip>5000</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clement Cezar Suñer, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Makati Medical Center</name>
      <address>
        <city>Makati City</city>
        <state>Metro Manila</state>
        <zip>1229</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joyce Anne Calulut</last_name>
    </contact>
    <contact_backup>
      <last_name>Joshua Allan Atienza</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>National Kidney and Transplant Institute</name>
      <address>
        <city>Quezon City</city>
        <state>Metro Manila</state>
        <zip>1101</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abigail Demetriou, RN</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Luke's Medical Center</name>
      <address>
        <city>Quezon City</city>
        <state>Metro Manila</state>
        <zip>1112</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shiela Calces</last_name>
    </contact>
    <contact_backup>
      <last_name>Lorraine Pelingen</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Cardinal Santos Medical Center (CSMC)</name>
      <address>
        <city>San Juan</city>
        <state>Metro Manila</state>
        <zip>1502</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marites Obra</last_name>
    </contact>
    <contact_backup>
      <last_name>Maria Lidda Dacanay</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>The Medical City Clark</name>
      <address>
        <city>Mabalacat</city>
        <state>Pampanga</state>
        <zip>2023</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kaye Ann Casulla</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Manila Doctors Hospital</name>
      <address>
        <city>Manila</city>
        <zip>1000</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire Sapelino</last_name>
      <phone>639189309218</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Medical City Ortigas</name>
      <address>
        <city>Manila</city>
        <zip>1605</zip>
        <country>Philippines</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abherdyn Caballero</last_name>
    </contact>
    <contact_backup>
      <phone>63178686448</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Uromed Jakub Koteras Twoja Przychodnia- Szczecińskie Centrum Medyczne</name>
      <address>
        <city>Szczecin</city>
        <state>Zachodniopomorskie</state>
        <zip>71434</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jakub Jaszczak, MSc.</last_name>
    </contact>
    <contact_backup>
      <last_name>Natalia Nowazyk, MSc.</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Vitamed Galaj i Cichomski Sp.j.</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85079</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rafal Cichomski, MSc.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Malgorzata Trzaska</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85794</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ewa Galczak-Nowak, MSc.</last_name>
    </contact>
    <contact_backup>
      <last_name>Natalia Ostojska</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Lukamed Joanna Luka Wendrowska</name>
      <address>
        <city>Chojnice</city>
        <zip>89600</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joanna Luka-Wendrowska, MSC</last_name>
    </contact>
    <contact_backup>
      <last_name>Aleksandra Niemczyk</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne MBB-MED</name>
      <address>
        <city>Chrzanów</city>
        <zip>32500</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jaroslaw Bigij</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne CLQ-MED</name>
      <address>
        <city>Grudziądz</city>
        <zip>86300</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dariusz Gajda</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Karkonoskie Centrum Badan Klinicznych Lexmedica Sp. z o.o</name>
      <address>
        <city>Jelenia Góra</city>
        <zip>58500</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hanna Durbajlo-Gradziel, MSc.</last_name>
    </contact>
    <contact_backup>
      <last_name>Justyna Lis, MSc.</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.</name>
      <address>
        <city>Ksawerów</city>
        <zip>95054</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Fortak-Michalska, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Twoja Przychodnia - Centrum Medyczne Nowa Sol</name>
      <address>
        <city>Nowa Sól</city>
        <zip>67100</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Agnieszka Antczak-Krawczyk, MSc.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Korczowski Bartosz, Gabinet Lekarski</name>
      <address>
        <city>Rzeszów</city>
        <zip>35-302</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Trela</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sonomed Sp. z o.o.</name>
      <address>
        <city>Szczecin</city>
        <zip>71685</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tomasz Kwiecień</last_name>
    </contact>
    <contact_backup>
      <last_name>Joanna Wasylów</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>WIP Warsaw IBD Point Prof. Kierkus</name>
      <address>
        <city>Warszawa</city>
        <zip>00728</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michal Baros</last_name>
    </contact>
    <contact_backup>
      <last_name>Joanna Blaszczak</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Medical Concierge Centrum Medyczne</name>
      <address>
        <city>Warszawa</city>
        <zip>02798</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Artur Lamparski, MSc.</last_name>
    </contact>
    <contact_backup>
      <last_name>Kamila Lewińska</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Melita Medical Centrum Medyczne</name>
      <address>
        <city>Wrocław</city>
        <zip>50449</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olga Kijora-Jaroszewska</last_name>
    </contact>
    <contact_backup>
      <last_name>Lech Kula</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Amicare</name>
      <address>
        <city>Łódź</city>
        <zip>91495</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rafal Drozda</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Colentina</name>
      <address>
        <city>Bucharest</city>
        <zip>020125</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Radu Gogdan Mateescu, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic 'Dr Ion Cantacuzino'</name>
      <address>
        <city>Bucharest</city>
        <zip>020475</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marilena Stoian</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>IC Fundeni 2 Gastro enterology department</name>
      <address>
        <city>Bucharest</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carmen Preda</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Spitalul Universitar de Urgenta Bucuresti</name>
      <address>
        <city>Bucharest</city>
        <zip>050098</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucian Negreanu, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Regional Institute of Gastroenterology</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400162</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christina Pojoga</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gastromedical SRL</name>
      <address>
        <city>Iaşi</city>
        <zip>707401</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anca Trifan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centrul de Gastroenterologie Dr. Goldis</name>
      <address>
        <city>Timişoara</city>
        <zip>300001</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adrian Goldis</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tirgu-Mures Country Clinical Hospital</name>
      <address>
        <city>Târgu-Mureş</city>
        <zip>540103</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniela Dobru</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Worthwhile Clinical Trials</name>
      <address>
        <city>Benoni</city>
        <zip>1500</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nazreen Hussen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Inspired GI Care</name>
      <address>
        <city>Cape Town</city>
        <zip>7800</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Naayil Rajabally</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wits Clinical Research</name>
      <address>
        <city>Johannesburg</city>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manoko Seabi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>EMMED</name>
      <address>
        <city>Pretoria</city>
        <zip>0002</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johannes Breedt</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Salud</name>
      <address>
        <city>Toledo</city>
        <state>Castilla La-Mancha</state>
        <zip>45004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Almudena Garcia Vela</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Dr. Negrín</name>
      <address>
        <city>Las Palmas De Gran Canaria</city>
        <state>Islas Canarias</state>
        <zip>35010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Cebalios Santos, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Fuenlabrada</name>
      <address>
        <city>Fuenlabrada</city>
        <state>Madrid</state>
        <zip>28942</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Jimenez Marquez</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra Hermida</last_name>
    </contact>
    <contact_backup>
      <last_name>Diana Acosta</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos and Instituto de Investigacion del Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Olivares</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Germany</country>
    <country>India</country>
    <country>Italy</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Hong Kong</country>
    <country>Russian Federation</country>
    <country>Ukraine</country>
  </removed_countries>
  <link>
    <url>http://cessa-uc.com</url>
    <description>A clinical study to evaluate the safety and effectiveness of an investigational hydrocortisone acetate 90 mg suppository administered with the Sephure applicator for the treatment of moderate to severe ulcerative colitis</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 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>Proctitis</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocortisone</mesh_term>
    <mesh_term>Hydrocortisone 17-butyrate 21-propionate</mesh_term>
    <mesh_term>Hydrocortisone acetate</mesh_term>
    <mesh_term>Hydrocortisone hemisuccinate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04469686
org study id: CHS1221
secondary id: 2019-003596-19
nct id: NCT04469686
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
A randomized, multi-center, double-blind, three arm placebo-controlled study in male and
      non-pregnant, non-lactating female subjects aged 18 years to examine the safety and efficacy
      of two dosing regimens of hydrocortisone acetate 90 mg suppository administered with the
      Sephure applicator for the treatment of ulcerative colitis of the rectum.
Hydrocortisone acetate 90 mg or placebo will be administered as a rectal suppository with a
      Sephure suppository applicator. Two arms of the study will receive different dosage regimens
      of hydrocortisone acetate, and the third arm will receive placebo. All subjects will
      administer the study drug twice a day; once in the morning and once in the evening for 28
      days.

      The study population will consist of male and non pregnant, non lactating females aged 18
      years and older with a confirmed diagnosis of active UC of the rectum.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Clinical remission measured using the Modified Mayo Score
time frame: 28 days
description: To evaluate the the efficacy of two dosage regimens of the study drug
measure: Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency
time frame: 28 days
description: To assess the change in stool frequency
measure: Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0
time frame: 28 days
description: To assess the change in rectal bleeding
measure: Quality of Life assessed measured using IBDQ validated questionnaire
time frame: 28 days
description: To examine the quality of life of patients
measure: Grading of disease severity measure using Mayo Scoring sub-score of Physician's Global Assessment
time frame: 28 days
description: To assess disease severity
measure: Concentrations of hydrocortisone acetate using pharmacokinetic sampling
time frame: 28 days
description: To evaluate the exposure of hydrocortisone acetate levels for safety
arm group label: Twice Daily - Active
arm group type: Experimental
description: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator
arm group label: Once Daily - Active
arm group type: Experimental
description: Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator
arm group label: Placebo
arm group type: Placebo Comparator
description: Twice daily placebo suppository administered with Sephure suppository applicator
intervention type: Combination Product
intervention name: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
description: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
arm group label: Twice Daily - Active
other name: Twice Daily - Active
intervention type: Combination Product
intervention name: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
description: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
arm group label: Once Daily - Active
other name: Once Daily - Active
intervention type: Combination Product
intervention name: Twice daily placebo suppository administered with Sephure applicator
description: Twice daily placebo suppository administered with Sephure applicator
arm group label: Placebo
other name: Twice Daily - Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karthik Devarajan, MD
role: Study Director
affiliation: Cristcot LLC
last name: Mark C Ensign
phone: 978-212-6380
email: mark.ensign@cristcot.com
last name: Lead Scientist
phone: 978-212-6380
email: research@cessa-uc.com
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contact: 
country: Denmark
country: Germany
country: India
country: Italy
country: Philippines
country: Poland
country: Romania
country: South Africa
country: Spain
country: United States
country: Hong Kong
country: Russian Federation
country: Ukraine
url: http://cessa-uc.com
description: A clinical study to evaluate the safety and effectiveness of an investigational hydrocortisone acetate 90 mg suppository administered with the Sephure applicator for the treatment of moderate to severe ulcerative colitis
responsible party type: Sponsor
mesh term: Proctitis
mesh term: Ulcer
mesh term: Hydrocortisone
mesh term: Hydrocortisone 17-butyrate 21-propionate
mesh term: Hydrocortisone acetate
mesh term: Hydrocortisone hemisuccinate
sharing ipd: No