<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/NCT02254486</url>
  </required_header>
  <id_info>
    <org_study_id>NER1006-01/2014 (NOCT)</org_study_id>
    <secondary_id>29672</secondary_id>
    <nct_id>NCT02254486</nct_id>
  </id_info>
  <brief_title>Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus Trisulfate Solution Using 2-Day Split-Dosing Regimen in Adults</brief_title>
  <acronym>NOCT</acronym>
  <official_title>A Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 (a Low Volume Bowel Cleansing Solution) Versus a Trisulfate Bowel Cleansing Solution Using 2-Day Split-Dosing Regimen in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norgine</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norgine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the efficacy, safety and tolerability of NER1006 versus Trisulfate&#xD;
      Solution (TS) in adult patients requiring bowel cleansing prior to any procedure that&#xD;
      requires a clean bowel, using a 2-Day evening/morning Split-Dosing regimen. Approximately 540&#xD;
      patients will be randomised with the aim of achieving a minimum of 245 patients in each of&#xD;
      the 2 groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Screening</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients With Successful Bowel Cleansing (Overall Colon)</measure>
    <time_frame>Two days (from day of first dosing to day of colonoscopy)</time_frame>
    <description>The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e., all mucosa could be visualised) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus Trisulfate solution was evaluated using a non-inferiority study design.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)</measure>
    <time_frame>Two days (from day of first dosing to day of colonoscopy)</time_frame>
    <description>The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus Trisulfate Solution was evaluated using a non-inferiority study design.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adenoma Detection Rate (Colon Ascendens)</measure>
    <time_frame>Two days (from day of first dosing to day of colonoscopy)</time_frame>
    <description>Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adenoma Detection Rate (Overall Colon)</measure>
    <time_frame>Two days (from day of first dosing to day of colonoscopy)</time_frame>
    <description>Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. ADR defined as the number of patients with at least one adenoma in the overall colon.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Polyp Detection Rate (Colon Ascendens)</measure>
    <time_frame>Two days (from day of first dosing to day of colonoscopy)</time_frame>
    <description>Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Polyp Detection Rate (Overall Colon)</measure>
    <time_frame>Two days (from day of first dosing to day of colonoscopy)</time_frame>
    <description>Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. PDR defined as the number of patients with at least one polyp in the overall colon.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">621</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Colorectal Carcinoma</condition>
  <condition>Colon Cleansing</condition>
  <arm_group>
    <arm_group_label>NER1006, 2-Day Split-Dosing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NER1006:2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trisulfate Solution, 2-Day Split-Dosing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trisulfate Solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NER1006</intervention_name>
    <description>The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.</description>
    <arm_group_label>NER1006, 2-Day Split-Dosing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trisulfate solution</intervention_name>
    <description>The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.</description>
    <arm_group_label>Trisulfate Solution, 2-Day Split-Dosing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Male and female outpatients and inpatients aged ≥18 to ≤85 years undergoing a&#xD;
             screening, surveillance, or diagnostic colonoscopy&#xD;
&#xD;
          -  Females of child bearing potential must have a negative pregnancy test at Screening&#xD;
             and at Visit 2 and must be practising one of the following methods of birth control&#xD;
             and agree to continue with the regimen throughout the study period: Oral, implantable,&#xD;
             or injectable contraceptives (for a minimum of three months before study entry) in&#xD;
             combination with a condom; Intrauterine device in combination with a condom; Double&#xD;
             barrier method (condom* and occlusive cap [diaphragm or cervical/vault caps] with&#xD;
             spermicidal foam/gel/film/cream/suppository)&#xD;
&#xD;
          -  Willing, able and competent to complete study and comply with instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with past history within last 12 months or current episode of severe&#xD;
             constipation (requiring repeated use of laxatives/enema or physical intervention&#xD;
             before resolution), known or suspected ileus, gastrointestinal obstruction, gastric&#xD;
             retention, bowel perforation, toxic colitis or megacolon.&#xD;
&#xD;
          -  Patients with ongoing severe acute Inflammatory Bowel Disease (IBD).&#xD;
&#xD;
          -  Patients who have had previous significant gastrointestinal surgeries, including&#xD;
             colonic resection, sub-total colectomy, abdomino-perineal resection, de-functioning&#xD;
             colostomy, Hartmann's procedure and de-functioning ileostomy or other similar&#xD;
             surgeries involving structure and function of the small or large colon.&#xD;
&#xD;
          -  Regular use of laxatives or colon motility altering drugs in the last month (i.e. more&#xD;
             than 2-3 times per week) and/or laxative use within 72 hours prior to administration&#xD;
             of the preparation.&#xD;
&#xD;
          -  Patients with active intestinal bleeding episodes or with a clinically significant low&#xD;
             hemoglobin level &lt;9 g/dL for women and &lt;11 g/dL for men at screening.&#xD;
&#xD;
          -  Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.&#xD;
&#xD;
          -  Known phenylketonuria.&#xD;
&#xD;
          -  Known hypersensitivity to polyethylene glycols, ascorbic acid and sulfates (not&#xD;
             including sulfa-based products) or any other component of the investigational product&#xD;
             or comparator.&#xD;
&#xD;
          -  Past history within the last 12 months or evidence of any on-going clinically relevant&#xD;
             electrocardiogram (ECG) abnormalities (e.g. arrhythmias).&#xD;
&#xD;
          -  History of uncontrolled hypertension with systolic blood pressure &gt;170 mmHg and&#xD;
             diastolic blood pressure &gt;100 mmHg.&#xD;
&#xD;
          -  Patients with cardiac insufficiency NYHA grades III or IV.&#xD;
&#xD;
          -  Patients with moderate to severe renal insufficiency (i.e. with GFR, &lt;60&#xD;
             mL/min/1.73m2).&#xD;
&#xD;
          -  Patient with serum albumin &lt; 3.4 g/dL.&#xD;
&#xD;
          -  Patients with liver disease of grades B and C according to the Child Pugh&#xD;
             classification.&#xD;
&#xD;
          -  Patients suffering from dehydration at screening as evaluated by the Investigator from&#xD;
             physical examination and laboratory investigations.&#xD;
&#xD;
          -  Patients with clinically significant electrolyte abnormalities, whether pre-existing&#xD;
             or noted at screening, such as hypernatremia, hyponatremia, hyperphosphatemia,&#xD;
             hypermagnesemia, hypokalemia, hypocalcaemia, dehydration, or those secondary to the&#xD;
             use of diuretics or angiotensin converting enzyme (ACE) inhibitors.&#xD;
&#xD;
          -  Patients with any other clinically significant hematological parameters including&#xD;
             coagulation profile at screening.&#xD;
&#xD;
          -  Patients with impaired consciousness that might predispose them to pulmonary&#xD;
             aspiration.&#xD;
&#xD;
          -  Patients undergoing colonoscopy for foreign body removal and/or decompression.&#xD;
&#xD;
          -  Patients who are pregnant or lactating, or intending to become pregnant during the&#xD;
             study.&#xD;
&#xD;
          -  Clinically relevant findings on physical examination based on the Investigator's&#xD;
             judgment.&#xD;
&#xD;
          -  History of drug or alcohol abuse within the 12 months prior to dosing.&#xD;
&#xD;
          -  Concurrent participation in an investigational drug or device study or participation&#xD;
             within three months of study entry.&#xD;
&#xD;
          -  Patients who, in the opinion of the Investigator, should not be included in the study&#xD;
             for any reason, including inability to follow study procedures, e.g. cognitively&#xD;
             impaired, debilitated or fragile patients.&#xD;
&#xD;
          -  Patients who are ordered to live in an institution on court or authority order.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Demicco</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anaheim Clinical Trials, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anaheim Clinical Trials</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Clinical Research</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MGG Group Co., Inc., Chevy Chase Clinical</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute of Michigan, LLC</name>
      <address>
        <city>Chesterfield</city>
        <state>Michigan</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Gastrointestinal Research Group, LLP</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cumberland Research Associates, LLC</name>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <zip>28304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peters Medical Research</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trial Management Associates, LLC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>24803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultants for Clinical Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Clinical Research, LLC</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>DeMicco MP, Clayton LB, Pilot J, Epstein MS; NOCT Study Group. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc. 2018 Mar;87(3):677-687.e3. doi: 10.1016/j.gie.2017.07.047. Epub 2017 Aug 10.</citation>
    <PMID>28803744</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <results_first_submitted>August 19, 2016</results_first_submitted>
  <results_first_submitted_qc>April 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 23, 2017</results_first_posted>
  <last_update_submitted>April 12, 2018</last_update_submitted>
  <last_update_submitted_qc>April 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2018</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>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial recruited out/in-patients at 12 medical centres in the USA, from September 2014 to May 2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Trisulfate Solution 2-Day Split-Dosing</title>
          <description>Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
        </group>
        <group group_id="P2">
          <title>NER1006 2-Day Split-Dosing</title>
          <description>NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="311"/>
                <participants group_id="P2" count="310"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="261"/>
                <participants group_id="P2" count="255"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>GFR&lt;60mL/min</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Various</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The number of participants for analysis, 245 per arm, was based on assumed overall cleansing success rates of 90% for both Trisulfate Solution (TS) and NER1006, a non-inferiority (NI) margin of 10%, and at least 90% power to demonstrate NI. The overall number of participants analyzed was based on the modified full analysis set (mFAS).</population>
      <group_list>
        <group group_id="B1">
          <title>Trisulfate Solution 2-Day Split-Dosing</title>
          <description>Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
        </group>
        <group group_id="B2">
          <title>NER1006 2-Day Split-Dosing</title>
          <description>NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
        </group>
        <group group_id="B3">
          <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="311"/>
            <count group_id="B2" value="310"/>
            <count group_id="B3" value="621"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="238"/>
                    <measurement group_id="B2" value="243"/>
                    <measurement group_id="B3" value="481"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="57.3" spread="10.56"/>
                    <measurement group_id="B2" value="57.7" spread="10.36"/>
                    <measurement group_id="B3" value="57.5" spread="10.44"/>
                  </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="142"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="294"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="169"/>
                    <measurement group_id="B2" value="158"/>
                    <measurement group_id="B3" value="327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Successful Bowel Cleansing (Overall Colon)</title>
        <description>The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e., all mucosa could be visualised) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus Trisulfate solution was evaluated using a non-inferiority study design.</description>
        <time_frame>Two days (from day of first dosing to day of colonoscopy)</time_frame>
        <population>The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Trisulfate Solution 2-Day Split-Dosing</title>
            <description>Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
          </group>
          <group group_id="O2">
            <title>NER1006 2-Day Split-Dosing</title>
            <description>NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Successful Bowel Cleansing (Overall Colon)</title>
          <description>The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e., all mucosa could be visualised) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus Trisulfate solution was evaluated using a non-inferiority study design.</description>
          <population>The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="276"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Successful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="238"/>
                    <measurement group_id="O2" value="235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.</non_inferiority_desc>
            <p_value>0.528</p_value>
            <p_value_desc>P-value adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value &lt;0.025, the threshold for statistical significance.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference in success rate</param_type>
            <param_value>0.14</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>-8.15</ci_lower_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)</title>
        <description>The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus Trisulfate Solution was evaluated using a non-inferiority study design.</description>
        <time_frame>Two days (from day of first dosing to day of colonoscopy)</time_frame>
        <population>The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Trisulfate Solution 2-Day Split-Dosing</title>
            <description>Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
          </group>
          <group group_id="O2">
            <title>NER1006 2-Day Split-Dosing</title>
            <description>NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)</title>
          <description>The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus Trisulfate Solution was evaluated using a non-inferiority study design.</description>
          <population>The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="276"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Excellent plus good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adequate plus failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="198"/>
                    <measurement group_id="O2" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.</non_inferiority_desc>
            <p_value>0.059</p_value>
            <p_value_desc>P-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority and with 1-sided p-value &lt;0.025; the threshold for statistical significance.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference in excellent plus good rate</param_type>
            <param_value>6.58</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>-1.69</ci_lower_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adenoma Detection Rate (Colon Ascendens)</title>
        <description>Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.</description>
        <time_frame>Two days (from day of first dosing to day of colonoscopy)</time_frame>
        <population>The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Trisulfate Solution 2-Day Split-Dosing</title>
            <description>Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
          </group>
          <group group_id="O2">
            <title>NER1006 2-Day Split-Dosing</title>
            <description>NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
          </group>
        </group_list>
        <measure>
          <title>Adenoma Detection Rate (Colon Ascendens)</title>
          <description>Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.</description>
          <population>The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="276"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patients with no adenomas detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="232"/>
                    <measurement group_id="O2" value="237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients with at least one adenoma detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.</non_inferiority_desc>
            <p_value>0.863</p_value>
            <p_value_desc>To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value &lt;0.025, the threshold for statistical significance.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference in ADR</param_type>
            <param_value>-3.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.36</ci_lower_limit>
            <ci_upper_limit>5.28</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adenoma Detection Rate (Overall Colon)</title>
        <description>Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. ADR defined as the number of patients with at least one adenoma in the overall colon.</description>
        <time_frame>Two days (from day of first dosing to day of colonoscopy)</time_frame>
        <population>The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Trisulfate Solution 2-Day Split-Dosing</title>
            <description>Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
          </group>
          <group group_id="O2">
            <title>NER1006 2-Day Split-Dosing</title>
            <description>NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
          </group>
        </group_list>
        <measure>
          <title>Adenoma Detection Rate (Overall Colon)</title>
          <description>Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. ADR defined as the number of patients with at least one adenoma in the overall colon.</description>
          <population>The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="276"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patients with no adenomas detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182"/>
                    <measurement group_id="O2" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients with at least one adenoma detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.</non_inferiority_desc>
            <p_value>0.660</p_value>
            <p_value_desc>To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value &lt;0.025, the threshold for statistical significance.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Polyp Detection Rate (Colon Ascendens)</title>
        <description>Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.</description>
        <time_frame>Two days (from day of first dosing to day of colonoscopy)</time_frame>
        <population>The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Trisulfate Solution 2-Day Split-Dosing</title>
            <description>Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
          </group>
          <group group_id="O2">
            <title>NER1006 2-Day Split-Dosing</title>
            <description>NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
          </group>
        </group_list>
        <measure>
          <title>Polyp Detection Rate (Colon Ascendens)</title>
          <description>Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.</description>
          <population>The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="276"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patients with no polyps detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="213"/>
                    <measurement group_id="O2" value="225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients with at least one polyp detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - Trisulfate Solution rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.</non_inferiority_desc>
            <p_value>0.953</p_value>
            <p_value_desc>To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value &lt;0.025, the threshold for statistical significance.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Polyp Detection Rate (Overall Colon)</title>
        <description>Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. PDR defined as the number of patients with at least one polyp in the overall colon.</description>
        <time_frame>Two days (from day of first dosing to day of colonoscopy)</time_frame>
        <population>The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Trisulfate Solution 2-Day Split-Dosing</title>
            <description>Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
          </group>
          <group group_id="O2">
            <title>NER1006 2-Day Split-Dosing</title>
            <description>NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
          </group>
        </group_list>
        <measure>
          <title>Polyp Detection Rate (Overall Colon)</title>
          <description>Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. PDR defined as the number of patients with at least one polyp in the overall colon.</description>
          <population>The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="276"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patients with no polyps detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients with at least one polyp detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136"/>
                    <measurement group_id="O2" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>If at least one of the alternative primary endpoints were met, then key secondary endpoints were evaluated hierarchichally in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit (CL) for difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of Trisulate Solution. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Formal hierarchical testing of this key secondary endpoints was not performed due to the results of the non-inferiority analysis.</non_inferiority_desc>
            <p_value>0.781</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Afternoon of Day 1 (first dose) to Day 9 (final clinic visit)</time_frame>
      <desc>Safety analyses were based on the safety population which included all randomized patients for whom it could not be ruled out (from their patient diary) that they received study drug at least once (n=527). The analyses are based on treatment emergent adverse events (TEAEs). There were no deaths and neither of the serious TEAEs was related to treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Trisulfate Solution 2-Day Split-Dosing</title>
          <description>Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
        </group>
        <group group_id="E2">
          <title>NER1006 2-Day Split-Dosing</title>
          <description>NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="262"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="262"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrintestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="262"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="265"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="262"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 18.0</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="32" subjects_at_risk="265"/>
                <counts group_id="E2" subjects_affected="73" subjects_at_risk="262"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="262"/>
              </event>
              <event>
                <sub_title>Abdominal Tenderness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="262"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="265"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="262"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="262"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="265"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="262"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="265"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="262"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="265"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="262"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="262"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="265"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="262"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="265"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="262"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="265"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="262"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Imputation of failure occurred in 7% of patients. This strict analytical approach reduced the cleansing success rates for both treatments.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Lucy Clayton</name_or_title>
      <organization>Norgine Ltd</organization>
      <phone>+44-1895-826669</phone>
      <email>lclayton@norgine.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/NCT02254486
org study id: NER1006-01/2014 (NOCT)
secondary id: 29672
nct id: NCT02254486
lead sponsor: 
has dmc: No
This study evaluates the efficacy, safety and tolerability of NER1006 versus Trisulfate
      Solution (TS) in adult patients requiring bowel cleansing prior to any procedure that
      requires a clean bowel, using a 2-Day evening/morning Split-Dosing regimen. Approximately 540
      patients will be randomised with the aim of achieving a minimum of 245 patients in each of
      the 2 groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Investigator)
measure: Number of Patients With Successful Bowel Cleansing (Overall Colon)
time frame: Two days (from day of first dosing to day of colonoscopy)
description: The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e., all mucosa could be visualised) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus Trisulfate solution was evaluated using a non-inferiority study design.
measure: Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
time frame: Two days (from day of first dosing to day of colonoscopy)
description: The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus Trisulfate Solution was evaluated using a non-inferiority study design.
measure: Adenoma Detection Rate (Colon Ascendens)
time frame: Two days (from day of first dosing to day of colonoscopy)
description: Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.
measure: Adenoma Detection Rate (Overall Colon)
time frame: Two days (from day of first dosing to day of colonoscopy)
description: Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. ADR defined as the number of patients with at least one adenoma in the overall colon.
measure: Polyp Detection Rate (Colon Ascendens)
time frame: Two days (from day of first dosing to day of colonoscopy)
description: Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.
measure: Polyp Detection Rate (Overall Colon)
time frame: Two days (from day of first dosing to day of colonoscopy)
description: Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. PDR defined as the number of patients with at least one polyp in the overall colon.
arm group label: NER1006, 2-Day Split-Dosing
arm group type: Experimental
description: NER1006:2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
arm group label: Trisulfate Solution, 2-Day Split-Dosing
arm group type: Active Comparator
description: Trisulfate Solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
intervention type: Drug
intervention name: NER1006
description: The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.
arm group label: NER1006, 2-Day Split-Dosing
intervention type: Drug
intervention name: Trisulfate solution
description: The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.
arm group label: Trisulfate Solution, 2-Day Split-Dosing
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Michael Demicco
role: Principal Investigator
affiliation: Anaheim Clinical Trials, CA
facility: 
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country: United States
citation: DeMicco MP, Clayton LB, Pilot J, Epstein MS; NOCT Study Group. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc. 2018 Mar;87(3):677-687.e3. doi: 10.1016/j.gie.2017.07.047. Epub 2017 Aug 10.
PMID: 28803744
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Imputation of failure occurred in 7% of patients. This strict analytical approach reduced the cleansing success rates for both treatments.
point of contact: 