<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/NCT02215954</url>
  </required_header>
  <id_info>
    <org_study_id>000176</org_study_id>
    <nct_id>NCT02215954</nct_id>
  </id_info>
  <brief_title>A Phase III Study With FE 999169 Versus Niflec for Colon Cleansing</brief_title>
  <official_title>A Phase III, Randomized, Assessor-Blinded, Parallel-Group, Multi-Centre, Clinical Study With FE 999169 for Oral Administration Versus Niflec® for Colon Cleansing: J-CLEAR</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate non inferiority of a) &quot;FE 999169 Split Dosing Schedule&quot; (one dose on the day&#xD;
      before and the second dose on the day of colonoscopy) and b) &quot;FE 999169 Day Before Dosing&#xD;
      Schedule&quot; (two doses on the day before colonoscopy) to &quot; Niflec On the Day Dosing Schedule&quot;&#xD;
      in subjects requiring colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a phase III, randomized, assessor-blinded, parallel-arm, multicenter, study in&#xD;
      Japanese patients. Patients, who signed an informed consent and fulfilled all screening&#xD;
      criteria, were randomized in a 1:1:1 ratio to one of the following 3 treatment groups: &quot;FE&#xD;
      999169 Split Dosing Schedule&quot;, &quot;FE 999169 Day Before Dosing Schedule&quot; and &quot; Niflec On the Day&#xD;
      Dosing Schedule&quot; in subjects requiring colonoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale</measure>
    <time_frame>Day 1 (day of colonoscopy)</time_frame>
    <description>The efficacy rate was based on the overall colon cleansing effect as assessed by the independent central judging committee: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Efficacy Rate Based on the Overall Colon Cleansing Effect Assessed by the Investigators at the Sites Using the Japanese Colon Cleansing Scale</measure>
    <time_frame>Day 1 (day of colonoscopy)</time_frame>
    <description>The efficacy rate was based on the overall colon cleansing effect as assessed by the investigators at sites: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale</measure>
    <time_frame>Day 1 (day of colonoscopy)</time_frame>
    <description>The total Ottawa scale score was calculated by adding the ratings (0 to 4) for each of the three colon segments, Ascending colon (ascending, cecum), Mid colon (transverse, descending), and Recto-sigmoid colon, in addition to the overall fluid quantity rating (0 (small), 1 (medium), or 2 (large) ). This gave a sum of 0 (best) to 12 (worst) for overall assessment of colon cleansing, and an additional 0 to 2 for the global fluid quantity rating. The final range of the score was from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire</measure>
    <time_frame>Day 0 - Day 1</time_frame>
    <description>The mean score of subjects who gave favourable impression on their assigned IMPs with 3 or 5 points scales, and the frequency of the response for yes/no questions was summarized in each of question for each treatment arm.&#xD;
Ease of consuming the assigned IMPs with a scale of 1(Very easy) to 5 (Very difficult)&#xD;
Overall impression of the assigned IMPs with a scale of 1(Excellent) to 5 (Bad)&#xD;
Taste of the assigned IMPs with a scale of 1 (Excellent) to 5 (Bad)&#xD;
Volume of the assigned IMPs with a scale of 1(Very much) to 3 (No problem)&#xD;
Impression of the assigned IMPs compared with other colon cleansing products with a scale of 1 (Much better) to 5 (Much worse)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire</measure>
    <time_frame>Day 0 - Day 1</time_frame>
    <description>The frequency of the response for yes/no questions was summarized in each of question for each treatment arm.&#xD;
Whether or not a subject will request for the assigned IMPs again when the next colonoscopy is needed, with yes-or-no answer&#xD;
Whether or not a subject will refuse the assigned IMPs when it is prescribed for the next colonoscopy, with yes-or-no answer</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">637</enrollment>
  <condition>Colon Cleansing in Preparation for Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Treatment arm [1]: FE 999169</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment arm [2]: FE 999169</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two sachets on the day before colonoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment arm [3]: Niflec</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One to two pack(s) on the day of colonoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FE 999169</intervention_name>
    <description>FE 999169 is a white crystalline powder for oral solution. Each sachet (16.1 g) contains sodium picosulfate hydrate 10 mg, magnesium oxide 3.5 g and anhydrous citric acid 12 g as well as orange flavour, potassium bicarbonate and sodium saccharin as excipients. FE 999916 is dissolved by mixing the contents of the sachet with approximately 150mL of cold water in a cup before administration.</description>
    <arm_group_label>Treatment arm [1]: FE 999169</arm_group_label>
    <arm_group_label>Treatment arm [2]: FE 999169</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niflec</intervention_name>
    <description>Niflec is a white-yellowish powder for oral solution. Each plastic sachet (137.155 g) contains sodium chloride 2.93 g, potassium chloride 1.485 g, sodium bicarbonate 3.37 g and sodium sulfate anhydrous 11.37 g, as well as macrogol 4000, saccharin sodium hydrate, flavour as excipients. Niflec is dissolved in water to make approximately 2 L of solution before administration.</description>
    <arm_group_label>Treatment arm [3]: Niflec</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Japanese patients, age 20 to 80 years inclusive, requiring colonoscopy&#xD;
&#xD;
          -  Female patients should be post-menopausal (women ≥45 years with no menstrual period&#xD;
             for at least 12 months without an alternative medical cause), or be surgically&#xD;
             sterile, or be using medically approved contraception, throughout the trial period.&#xD;
&#xD;
          -  Fertile female patients must have a confirmed negative pregnancy test at screening and&#xD;
             randomization&#xD;
&#xD;
          -  Patients must have had more than or equal to 3 spontaneous bowel movements per week&#xD;
             prior to the colonoscopy&#xD;
&#xD;
          -  Written informed consent obtained prior to any study-related procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute surgical abdominal conditions, such as acute intestinal obstruction or&#xD;
             intestinal perforation, diverticulitis, appendicitis. If intestinal obstruction and&#xD;
             perforation are suspected, perform appropriate diagnostic studies to rule out these&#xD;
             conditions&#xD;
&#xD;
          -  Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)&#xD;
&#xD;
          -  Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior&#xD;
             endoscopic procedures&#xD;
&#xD;
          -  Colon disease (history of colonic cancer, toxic megacolon, idiopathic&#xD;
             pseudo-obstruction, hypomotility syndrome)&#xD;
&#xD;
          -  Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis,&#xD;
             ileus)&#xD;
&#xD;
          -  Ascites.&#xD;
&#xD;
          -  Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)&#xD;
&#xD;
          -  Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive&#xD;
             Heart Failure (CHF), or uncontrolled hypertension&#xD;
&#xD;
          -  Renal insufficiency (any of the serum creatinine, or serum potassium value exceeding&#xD;
             the upper limits of the normal range at screening) or a history of this event&#xD;
&#xD;
          -  Participation in any other clinical trial during the past 3 months&#xD;
&#xD;
          -  Any clinically significant laboratory value at screening, including pre-existing&#xD;
             electrolyte abnormality, based on clinical history that the investigators feel may&#xD;
             affect the study evaluation&#xD;
&#xD;
          -  Hypersensitivity to active ingredients&#xD;
&#xD;
          -  Subject who cannot suspend the prohibited medications&#xD;
&#xD;
          -  Subjects not appropriate to participate in the study as deemed by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Development Support</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Kochi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <results_first_submitted>October 24, 2016</results_first_submitted>
  <results_first_submitted_qc>April 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 17, 2017</results_first_posted>
  <last_update_submitted>April 18, 2017</last_update_submitted>
  <last_update_submitted_qc>April 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Arm [1]: FE 999169</title>
          <description>One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy&#xD;
FE 999169</description>
        </group>
        <group group_id="P2">
          <title>Treatment Arm [2]: FE 999169</title>
          <description>Two sachets on the day before colonoscopy&#xD;
FE 999169</description>
        </group>
        <group group_id="P3">
          <title>Treatment Arm [3]: Niflec</title>
          <description>One to two pack(s) on the day of colonoscopy&#xD;
Niflec</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="214"/>
                <participants group_id="P2" count="212"/>
                <participants group_id="P3" count="211"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intention-To-Treat (ITT) Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="214"/>
                <participants group_id="P2" count="212"/>
                <participants group_id="P3" count="211"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per Protocol (PP) Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="212"/>
                <participants group_id="P2" count="208"/>
                <participants group_id="P3" count="205"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="213"/>
                <participants group_id="P2" count="211"/>
                <participants group_id="P3" count="208"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="213"/>
                <participants group_id="P2" count="211"/>
                <participants group_id="P3" count="205"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not exposed</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intention-To-Treat Analysis set</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment Arm [1]: FE 999169</title>
          <description>One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy&#xD;
FE 999169</description>
        </group>
        <group group_id="B2">
          <title>Treatment Arm [2]: FE 999169</title>
          <description>Two sachets on the day before colonoscopy&#xD;
FE 999169</description>
        </group>
        <group group_id="B3">
          <title>Treatment Arm [3]: Niflec</title>
          <description>One to two pack(s) on the day of colonoscopy&#xD;
Niflec</description>
        </group>
        <group group_id="B4">
          <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="214"/>
            <count group_id="B2" value="212"/>
            <count group_id="B3" value="211"/>
            <count group_id="B4" value="637"/>
          </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="48.1" spread="14.0"/>
                    <measurement group_id="B2" value="48.3" spread="14.3"/>
                    <measurement group_id="B3" value="48.1" spread="14.1"/>
                    <measurement group_id="B4" value="48.2" spread="14.1"/>
                  </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="102"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="95"/>
                    <measurement group_id="B4" value="297"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="116"/>
                    <measurement group_id="B4" value="340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>(m)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.64" spread="0.080"/>
                    <measurement group_id="B2" value="1.64" spread="0.082"/>
                    <measurement group_id="B3" value="1.64" spread="0.084"/>
                    <measurement group_id="B4" value="1.64" spread="0.082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>(kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.9" spread="11.6"/>
                    <measurement group_id="B2" value="63.1" spread="13.0"/>
                    <measurement group_id="B3" value="62.6" spread="12.5"/>
                    <measurement group_id="B4" value="62.5" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>(kg/m2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.9" spread="3.20"/>
                    <measurement group_id="B2" value="23.2" spread="3.59"/>
                    <measurement group_id="B3" value="23.2" spread="3.72"/>
                    <measurement group_id="B4" value="23.1" spread="3.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale</title>
        <description>The efficacy rate was based on the overall colon cleansing effect as assessed by the independent central judging committee: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.</description>
        <time_frame>Day 1 (day of colonoscopy)</time_frame>
        <population>Intention-To-Treat Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm [1]: FE 999169</title>
            <description>One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy&#xD;
FE 999169</description>
          </group>
          <group group_id="O2">
            <title>Treatment Arm [2]: FE 999169</title>
            <description>Two sachets on the day before colonoscopy&#xD;
FE 999169</description>
          </group>
          <group group_id="O3">
            <title>Treatment Arm [3]: Niflec</title>
            <description>One to two pack(s) on the day of colonoscopy&#xD;
Niflec</description>
          </group>
        </group_list>
        <measure>
          <title>The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale</title>
          <description>The efficacy rate was based on the overall colon cleansing effect as assessed by the independent central judging committee: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.</description>
          <population>Intention-To-Treat Analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="212"/>
                <count group_id="O3" value="211"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7"/>
                    <measurement group_id="O2" value="92.0"/>
                    <measurement group_id="O3" value="95.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Efficacy Rate Based on the Overall Colon Cleansing Effect Assessed by the Investigators at the Sites Using the Japanese Colon Cleansing Scale</title>
        <description>The efficacy rate was based on the overall colon cleansing effect as assessed by the investigators at sites: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.</description>
        <time_frame>Day 1 (day of colonoscopy)</time_frame>
        <population>Intention-To-Treat Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm [1]: FE 999169</title>
            <description>One sachet of the day before colonoscopy, and another sachet on the day of colonoscopy&#xD;
FE 999169</description>
          </group>
          <group group_id="O2">
            <title>Treatment Arm [2]: FE 999169</title>
            <description>Two sachets on the day before colonoscopy&#xD;
FE 999169</description>
          </group>
          <group group_id="O3">
            <title>Treatment Arm [3]: Niflec</title>
            <description>One to two pack(s) on the day of colonoscopy&#xD;
Niflec</description>
          </group>
        </group_list>
        <measure>
          <title>The Efficacy Rate Based on the Overall Colon Cleansing Effect Assessed by the Investigators at the Sites Using the Japanese Colon Cleansing Scale</title>
          <description>The efficacy rate was based on the overall colon cleansing effect as assessed by the investigators at sites: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.</description>
          <population>Intention-To-Treat Analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="212"/>
                <count group_id="O3" value="211"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.8"/>
                    <measurement group_id="O2" value="79.7"/>
                    <measurement group_id="O3" value="93.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale</title>
        <description>The total Ottawa scale score was calculated by adding the ratings (0 to 4) for each of the three colon segments, Ascending colon (ascending, cecum), Mid colon (transverse, descending), and Recto-sigmoid colon, in addition to the overall fluid quantity rating (0 (small), 1 (medium), or 2 (large) ). This gave a sum of 0 (best) to 12 (worst) for overall assessment of colon cleansing, and an additional 0 to 2 for the global fluid quantity rating. The final range of the score was from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).</description>
        <time_frame>Day 1 (day of colonoscopy)</time_frame>
        <population>Intention-To-Treat Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm [1]: FE 999169</title>
            <description>One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy&#xD;
FE 999169</description>
          </group>
          <group group_id="O2">
            <title>Treatment Arm [2]: FE 999169</title>
            <description>Two sachets on the day before colonoscopy&#xD;
FE 999169</description>
          </group>
          <group group_id="O3">
            <title>Treatment Arm [3]: Niflec</title>
            <description>One to two pack(s) on the day of colonoscopy&#xD;
Niflec</description>
          </group>
        </group_list>
        <measure>
          <title>The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale</title>
          <description>The total Ottawa scale score was calculated by adding the ratings (0 to 4) for each of the three colon segments, Ascending colon (ascending, cecum), Mid colon (transverse, descending), and Recto-sigmoid colon, in addition to the overall fluid quantity rating (0 (small), 1 (medium), or 2 (large) ). This gave a sum of 0 (best) to 12 (worst) for overall assessment of colon cleansing, and an additional 0 to 2 for the global fluid quantity rating. The final range of the score was from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).</description>
          <population>Intention-To-Treat Analysis set</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="212"/>
                <count group_id="O3" value="211"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.31" lower_limit="3.94" upper_limit="4.67"/>
                    <measurement group_id="O2" value="5.18" lower_limit="4.81" upper_limit="5.54"/>
                    <measurement group_id="O3" value="2.33" lower_limit="1.96" upper_limit="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire</title>
        <description>The mean score of subjects who gave favourable impression on their assigned IMPs with 3 or 5 points scales, and the frequency of the response for yes/no questions was summarized in each of question for each treatment arm.&#xD;
Ease of consuming the assigned IMPs with a scale of 1(Very easy) to 5 (Very difficult)&#xD;
Overall impression of the assigned IMPs with a scale of 1(Excellent) to 5 (Bad)&#xD;
Taste of the assigned IMPs with a scale of 1 (Excellent) to 5 (Bad)&#xD;
Volume of the assigned IMPs with a scale of 1(Very much) to 3 (No problem)&#xD;
Impression of the assigned IMPs compared with other colon cleansing products with a scale of 1 (Much better) to 5 (Much worse)</description>
        <time_frame>Day 0 - Day 1</time_frame>
        <population>Intention-To-Treat Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm [1]: FE 999169</title>
            <description>One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy&#xD;
FE 999169</description>
          </group>
          <group group_id="O2">
            <title>Treatment Arm [2]: FE 999169</title>
            <description>Two sachets on the day before colonoscopy&#xD;
FE 999169</description>
          </group>
          <group group_id="O3">
            <title>Treatment Arm [3]: Niflec</title>
            <description>One to two pack(s) on the day of colonoscopy&#xD;
Niflec</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire</title>
          <description>The mean score of subjects who gave favourable impression on their assigned IMPs with 3 or 5 points scales, and the frequency of the response for yes/no questions was summarized in each of question for each treatment arm.&#xD;
Ease of consuming the assigned IMPs with a scale of 1(Very easy) to 5 (Very difficult)&#xD;
Overall impression of the assigned IMPs with a scale of 1(Excellent) to 5 (Bad)&#xD;
Taste of the assigned IMPs with a scale of 1 (Excellent) to 5 (Bad)&#xD;
Volume of the assigned IMPs with a scale of 1(Very much) to 3 (No problem)&#xD;
Impression of the assigned IMPs compared with other colon cleansing products with a scale of 1 (Much better) to 5 (Much worse)</description>
          <population>Intention-To-Treat Analysis set</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="212"/>
                <count group_id="O3" value="211"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IMP compliance, easy or difficult</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.86" lower_limit="1.75" upper_limit="1.97"/>
                    <measurement group_id="O2" value="1.98" lower_limit="1.87" upper_limit="2.08"/>
                    <measurement group_id="O3" value="3.08" lower_limit="2.97" upper_limit="3.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall impression of assigned IMP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.07" lower_limit="1.97" upper_limit="2.18"/>
                    <measurement group_id="O2" value="2.10" lower_limit="2.00" upper_limit="2.21"/>
                    <measurement group_id="O3" value="2.85" lower_limit="2.75" upper_limit="2.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taste of assigned IMP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.08" lower_limit="1.96" upper_limit="2.19"/>
                    <measurement group_id="O2" value="2.23" lower_limit="2.12" upper_limit="2.35"/>
                    <measurement group_id="O3" value="3.19" lower_limit="3.08" upper_limit="3.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Volume of IMP consumption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.90" lower_limit="2.84" upper_limit="2.97"/>
                    <measurement group_id="O2" value="2.89" lower_limit="2.82" upper_limit="2.96"/>
                    <measurement group_id="O3" value="2.23" lower_limit="2.17" upper_limit="2.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Comparison with previously colon cleansing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.83" lower_limit="1.52" upper_limit="2.14"/>
                    <measurement group_id="O2" value="2.22" lower_limit="1.86" upper_limit="2.58"/>
                    <measurement group_id="O3" value="2.77" lower_limit="2.48" upper_limit="3.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire</title>
        <description>The frequency of the response for yes/no questions was summarized in each of question for each treatment arm.&#xD;
Whether or not a subject will request for the assigned IMPs again when the next colonoscopy is needed, with yes-or-no answer&#xD;
Whether or not a subject will refuse the assigned IMPs when it is prescribed for the next colonoscopy, with yes-or-no answer</description>
        <time_frame>Day 0 - Day 1</time_frame>
        <population>Intention-To-Treat Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm [1]: FE 999169</title>
            <description>One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy&#xD;
FE 999169</description>
          </group>
          <group group_id="O2">
            <title>Treatment Arm [2]: FE 999169</title>
            <description>Two sachets on the day before colonoscopy&#xD;
FE 999169</description>
          </group>
          <group group_id="O3">
            <title>Treatment Arm [3]: Niflec</title>
            <description>One to two pack(s) on the day of colonoscopy&#xD;
Niflec</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire</title>
          <description>The frequency of the response for yes/no questions was summarized in each of question for each treatment arm.&#xD;
Whether or not a subject will request for the assigned IMPs again when the next colonoscopy is needed, with yes-or-no answer&#xD;
Whether or not a subject will refuse the assigned IMPs when it is prescribed for the next colonoscopy, with yes-or-no answer</description>
          <population>Intention-To-Treat Analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="212"/>
                <count group_id="O3" value="211"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Wish to use the same drug in future</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3" lower_limit="87.8" upper_limit="95.2"/>
                    <measurement group_id="O2" value="88.5" lower_limit="83.4" upper_limit="92.1"/>
                    <measurement group_id="O3" value="60.9" lower_limit="54.0" upper_limit="67.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Refuse to use the same drug in future</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" lower_limit="1.2" upper_limit="5.8"/>
                    <measurement group_id="O2" value="4.5" lower_limit="2.4" upper_limit="8.3"/>
                    <measurement group_id="O3" value="11.2" lower_limit="7.5" upper_limit="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Treatment Arm [1]: FE 999169</title>
          <description>One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy&#xD;
FE 999169</description>
        </group>
        <group group_id="E2">
          <title>Treatment Arm [2]: FE 999169</title>
          <description>Two sachets on the day before colonoscopy&#xD;
FE 999169</description>
        </group>
        <group group_id="E3">
          <title>Treatment Arm [3]: Niflec</title>
          <description>One to two pack(s) on the day of colonoscopy&#xD;
Niflec</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="208"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Post-procedual haemorrhage</sub_title>
                <description>The Investigator reported the event to be related with the endoscopic mucosal resection procedure.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="208"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Non-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="6" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="208"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="213"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="211"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="208"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood magnesium increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="211"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="208"/>
              </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 only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Development Support</name_or_title>
      <organization>Ferring Pharmaceuticals</organization>
      <email>DK0-Disclosure@ferring.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/NCT02215954
org study id: 000176
nct id: NCT02215954
lead sponsor: 
has dmc: No
To demonstrate non inferiority of a) "FE 999169 Split Dosing Schedule" (one dose on the day
      before and the second dose on the day of colonoscopy) and b) "FE 999169 Day Before Dosing
      Schedule" (two doses on the day before colonoscopy) to " Niflec On the Day Dosing Schedule"
      in subjects requiring colonoscopy.
This was a phase III, randomized, assessor-blinded, parallel-arm, multicenter, study in
      Japanese patients. Patients, who signed an informed consent and fulfilled all screening
      criteria, were randomized in a 1:1:1 ratio to one of the following 3 treatment groups: "FE
      999169 Split Dosing Schedule", "FE 999169 Day Before Dosing Schedule" and " Niflec On the Day
      Dosing Schedule" in subjects requiring colonoscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale
time frame: Day 1 (day of colonoscopy)
description: The efficacy rate was based on the overall colon cleansing effect as assessed by the independent central judging committee: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.
measure: The Efficacy Rate Based on the Overall Colon Cleansing Effect Assessed by the Investigators at the Sites Using the Japanese Colon Cleansing Scale
time frame: Day 1 (day of colonoscopy)
description: The efficacy rate was based on the overall colon cleansing effect as assessed by the investigators at sites: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.
measure: The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale
time frame: Day 1 (day of colonoscopy)
description: The total Ottawa scale score was calculated by adding the ratings (0 to 4) for each of the three colon segments, Ascending colon (ascending, cecum), Mid colon (transverse, descending), and Recto-sigmoid colon, in addition to the overall fluid quantity rating (0 (small), 1 (medium), or 2 (large) ). This gave a sum of 0 (best) to 12 (worst) for overall assessment of colon cleansing, and an additional 0 to 2 for the global fluid quantity rating. The final range of the score was from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).
measure: Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
time frame: Day 0 - Day 1
description: The mean score of subjects who gave favourable impression on their assigned IMPs with 3 or 5 points scales, and the frequency of the response for yes/no questions was summarized in each of question for each treatment arm.
Ease of consuming the assigned IMPs with a scale of 1(Very easy) to 5 (Very difficult)
Overall impression of the assigned IMPs with a scale of 1(Excellent) to 5 (Bad)
Taste of the assigned IMPs with a scale of 1 (Excellent) to 5 (Bad)
Volume of the assigned IMPs with a scale of 1(Very much) to 3 (No problem)
Impression of the assigned IMPs compared with other colon cleansing products with a scale of 1 (Much better) to 5 (Much worse)
measure: Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
time frame: Day 0 - Day 1
description: The frequency of the response for yes/no questions was summarized in each of question for each treatment arm.
Whether or not a subject will request for the assigned IMPs again when the next colonoscopy is needed, with yes-or-no answer
Whether or not a subject will refuse the assigned IMPs when it is prescribed for the next colonoscopy, with yes-or-no answer
arm group label: Treatment arm [1]: FE 999169
arm group type: Experimental
description: One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
arm group label: Treatment arm [2]: FE 999169
arm group type: Experimental
description: Two sachets on the day before colonoscopy
arm group label: Treatment arm [3]: Niflec
arm group type: Active Comparator
description: One to two pack(s) on the day of colonoscopy
intervention type: Drug
intervention name: FE 999169
description: FE 999169 is a white crystalline powder for oral solution. Each sachet (16.1 g) contains sodium picosulfate hydrate 10 mg, magnesium oxide 3.5 g and anhydrous citric acid 12 g as well as orange flavour, potassium bicarbonate and sodium saccharin as excipients. FE 999916 is dissolved by mixing the contents of the sachet with approximately 150mL of cold water in a cup before administration.
arm group label: Treatment arm [1]: FE 999169
arm group label: Treatment arm [2]: FE 999169
intervention type: Drug
intervention name: Niflec
description: Niflec is a white-yellowish powder for oral solution. Each plastic sachet (137.155 g) contains sodium chloride 2.93 g, potassium chloride 1.485 g, sodium bicarbonate 3.37 g and sodium sulfate anhydrous 11.37 g, as well as macrogol 4000, saccharin sodium hydrate, flavour as excipients. Niflec is dissolved in water to make approximately 2 L of solution before administration.
arm group label: Treatment arm [3]: Niflec
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Clinical Development Support
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 