<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/NCT02246686</url>
  </required_header>
  <id_info>
    <org_study_id>17155</org_study_id>
    <secondary_id>2013-000891-13</secondary_id>
    <nct_id>NCT02246686</nct_id>
  </id_info>
  <brief_title>Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients</brief_title>
  <official_title>A Randomised, Double-blind, Placebo-controlled Multi-centre Study to Investigate the Effectiveness and Safety of STW5-II as add-on Treatment for Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in&#xD;
      patients with mild to moderate ulcerative colitis in an acute flare.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients being in remission at final visit</measure>
    <time_frame>Week 12</time_frame>
    <description>Responder definition for remission: Clinical Activity Index (CAI) ≤ 4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of endoscopic index (EI)</measure>
    <time_frame>From baseline to week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of histological index (HI) based on Riley</measure>
    <time_frame>From baseline to week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients reaching a clinical CAI ≤ 2 points</measure>
    <time_frame>Week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to remission, defined as days from Day 0 until first remission is reached</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Responder definition for remission: Clinical Activity Index (CAI) ≤ 4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients who reached a remission at least once during the course of the study</measure>
    <time_frame>Week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients who reached a sustained remission at least once during the course of the study</measure>
    <time_frame>Week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of absolute CAI values to final visit</measure>
    <time_frame>From baseline to week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit</measure>
    <time_frame>From baseline to week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit</measure>
    <time_frame>From baseline to week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit</measure>
    <time_frame>From baseline to week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mayo Score throughout the study</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of of oral mesalazine dose throughout the study period</measure>
    <time_frame>From baseline to week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in ulcerative colitis (UC) markers</measure>
    <time_frame>From baseline to week 12</time_frame>
    <description>Combination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Colitis, Ulcerative</condition>
  <arm_group>
    <arm_group_label>STW5-II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Half of study population, assigned randomly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Half of study population, assigned randomly</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>STW5-II (Iberogast N, BAY98-7410)</intervention_name>
    <description>Application over 12 weeks 20 drops three time daily</description>
    <arm_group_label>STW5-II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Application over 12 weeks 20 drops three time daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with mild to moderate active ulcerative colitis (UC), i.e. Clinical Activity&#xD;
             Index (CAI) ≥ 5 up to 10 points (including)&#xD;
&#xD;
          -  Patients in whom the active UC is treated independent from any participation in the&#xD;
             current study with oral mesalazine at least 14 days up to maximal 28 days before Visit&#xD;
             2&#xD;
&#xD;
          -  Age between 18 to 80 years (including)&#xD;
&#xD;
          -  UC may reach from left-sided colitis to pancolitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe forms of UC (CAI &gt; 10)&#xD;
&#xD;
          -  Crohn's disease, infectious colitis or undetermined colitis&#xD;
&#xD;
          -  Steroid dependence and steroid resistance&#xD;
&#xD;
          -  Concomitant medication with oral steroids, oral or topic budesonide, biologicals,&#xD;
             immune modifiers, immunosuppressants&#xD;
&#xD;
          -  Antibiotics at screening visit, during the course of the study a short-term use in&#xD;
             non-colitic afflictions is allowed, and is documented&#xD;
&#xD;
          -  Prior medication with biologicals, immune modifiers and immunosuppressants &lt; 3 month&#xD;
             wash-out&#xD;
&#xD;
          -  Total colectomy&#xD;
&#xD;
          -  Known allergies to components of STW5-II&#xD;
&#xD;
          -  Severe allergic diathesis&#xD;
&#xD;
          -  Topical mesalazine application&#xD;
&#xD;
          -  Known intolerance to azo dyes E110 and E151&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Dachau</city>
        <state>Bayern</state>
        <zip>85221</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lüneburg</city>
        <state>Niedersachsen</state>
        <zip>21339</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Köln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ludwigshafen</city>
        <state>Rheinland-Pfalz</state>
        <zip>67067</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lübeck</city>
        <state>Schleswig-Holstein</state>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <zip>14109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Essen</city>
        <zip>45276</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamburg</city>
        <zip>20249</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>October 17, 2016</last_update_submitted>
  <last_update_submitted_qc>October 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Iberogast N</keyword>
  <keyword>Mild to moderate ulcerative colitis</keyword>
  <keyword>add-on therapy</keyword>
  <keyword>efficacy</keyword>
  <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>
  <!-- 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/NCT02246686
org study id: 17155
secondary id: 2013-000891-13
nct id: NCT02246686
lead sponsor: 
has dmc: No
The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in
      patients with mild to moderate ulcerative colitis in an acute flare.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Proportion of patients being in remission at final visit
time frame: Week 12
description: Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
measure: Change of endoscopic index (EI)
time frame: From baseline to week 12
measure: Change of histological index (HI) based on Riley
time frame: From baseline to week 12
measure: Proportion of patients reaching a clinical CAI ≤ 2 points
time frame: Week 12
measure: Time to remission, defined as days from Day 0 until first remission is reached
time frame: Up to 12 weeks
description: Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
measure: Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached
time frame: Up to 12 weeks
measure: Number of patients who reached a remission at least once during the course of the study
time frame: Week 12
measure: Number of patients who reached a sustained remission at least once during the course of the study
time frame: Week 12
measure: Change from baseline of absolute CAI values to final visit
time frame: From baseline to week 12
measure: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit
time frame: From baseline to week 12
measure: Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit
time frame: From baseline to week 12
measure: Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit
time frame: From baseline to week 12
measure: Mayo Score throughout the study
time frame: Up to 12 weeks
measure: Change of of oral mesalazine dose throughout the study period
time frame: From baseline to week 12
measure: Change in ulcerative colitis (UC) markers
time frame: From baseline to week 12
description: Combination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients
arm group label: STW5-II
arm group type: Experimental
description: Half of study population, assigned randomly
arm group label: Placebo
arm group type: Placebo Comparator
description: Half of study population, assigned randomly
intervention type: Drug
intervention name: STW5-II (Iberogast N, BAY98-7410)
description: Application over 12 weeks 20 drops three time daily
arm group label: STW5-II
intervention type: Drug
intervention name: Placebo
description: Application over 12 weeks 20 drops three time daily
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer