<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/NCT01694966</url>
  </required_header>
  <id_info>
    <org_study_id>CB-17-01/06</org_study_id>
    <secondary_id>2012-003983-32</secondary_id>
    <nct_id>NCT01694966</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy</brief_title>
  <official_title>The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cosmo Technologies Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CosmoTech</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the histologically proven adenoma and carcinoma detection rate in patients&#xD;
      undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with&#xD;
      200 mg of Methylene Blue MMX® tablets.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.</measure>
    <time_frame>+7 days</time_frame>
    <description>Adenoma Detection Rate</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1249</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Methylene Blue MMX® 200mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methylene Blue MMX® 100mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral dose, 8 Placebo tablets over a 4hr schedule</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylene Blue MMX®</intervention_name>
    <arm_group_label>Methylene Blue MMX® 100mg</arm_group_label>
    <arm_group_label>Methylene Blue MMX® 200mg</arm_group_label>
    <other_name>Investigational Product: Methylene Blue MMX® modified release tablets</other_name>
    <other_name>Active Ingredient: Methylene Blue</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sugar pill manufactured to mimic Methylene Blue MMX® tablet.</description>
    <arm_group_label>Methylene Blue MMX® 100mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females, aged between 50 and 75.&#xD;
&#xD;
          -  Outpatients scheduled for screening or surveillance colonoscopy for polyps or&#xD;
             colorectal cancer )&#xD;
&#xD;
          -  Able to comprehend the full nature and purpose of the study, including possible risks&#xD;
             and side effects.&#xD;
&#xD;
          -  Able to co-operate with the investigator and to comply with the requirements of the&#xD;
             entire study.&#xD;
&#xD;
          -  Signed written informed consent prior to inclusion in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients at high risk of colorectal cancer e.g. ulcerative colitis&#xD;
&#xD;
          -  Previous medical history of, or suspected hypersensitivity to, the Methylene Blue&#xD;
             and/or formulations' ingredients.&#xD;
&#xD;
          -  Previous medical history of, or suspected hypersensitivity to, the PEG based bowel&#xD;
             cleansing preparation and/or bowel cleansing formulations' ingredients.&#xD;
&#xD;
          -  Previous medical history of gastrointestinal obstruction or perforation, toxic&#xD;
             megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or&#xD;
             IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessandro Repici, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Co-ordinating Investigator EU</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Wallace, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Co-ordinating Investigator US</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr Michelle Young</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Francesco Ramirez</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr David Gatof</name>
      <address>
        <city>Lafayette</city>
        <state>Colorado</state>
        <zip>80026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Michael Wallace</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Prateek Sharma</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Marcia Canto</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr David Bruining</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Raf Bisschop</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Norman Marcon</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Ralf Kiesslich</name>
      <address>
        <city>Wiesbaden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Renato Cannizzaro</name>
      <address>
        <city>Aviano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Cesare Hassan</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Alessandro Repici</name>
      <address>
        <city>Rozzano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Limas Kupcinskas</name>
      <address>
        <city>Kaunas</city>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Evelien Dekker</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Manoon Spander</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Peter Siersema</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr James East</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Matthew Rutter</name>
      <address>
        <city>Stockton-on-Tees</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Lithuania</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <results_first_submitted>August 25, 2017</results_first_submitted>
  <results_first_submitted_qc>October 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 6, 2017</results_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylene Blue</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Methylene Blue MMX® 200mg</title>
          <description>Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule&#xD;
Methylene Blue MMX®</description>
        </group>
        <group group_id="P2">
          <title>Methylene Blue MMX® 100mg</title>
          <description>Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule&#xD;
Methylene Blue MMX®&#xD;
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Oral dose, 8 Placebo tablets over a 4hr schedule&#xD;
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="504"/>
                <participants group_id="P2" count="247"/>
                <participants group_id="P3" count="498"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="470"/>
                <participants group_id="P2" count="232"/>
                <participants group_id="P3" count="464"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="34"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Methylene Blue MMX® 200mg</title>
          <description>Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule&#xD;
Methylene Blue MMX®</description>
        </group>
        <group group_id="B2">
          <title>Methylene Blue MMX® 100mg</title>
          <description>Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule&#xD;
Methylene Blue MMX®&#xD;
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Oral dose, 8 Placebo tablets over a 4hr schedule&#xD;
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.</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="504"/>
            <count group_id="B2" value="247"/>
            <count group_id="B3" value="498"/>
            <count group_id="B4" value="1249"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>ITT=1249, FAS=1205</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="485"/>
                    <count group_id="B2" value="241"/>
                    <count group_id="B3" value="479"/>
                    <count group_id="B4" value="1205"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="313"/>
                    <measurement group_id="B2" value="163"/>
                    <measurement group_id="B3" value="298"/>
                    <measurement group_id="B4" value="774"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="172"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="181"/>
                    <measurement group_id="B4" value="431"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>ITT=1249 FAS=1205</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="485"/>
                    <count group_id="B2" value="241"/>
                    <count group_id="B3" value="479"/>
                    <count group_id="B4" value="1205"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="191"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="184"/>
                    <measurement group_id="B4" value="478"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="294"/>
                    <measurement group_id="B2" value="138"/>
                    <measurement group_id="B3" value="295"/>
                    <measurement group_id="B4" value="727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.</title>
        <description>Adenoma Detection Rate</description>
        <time_frame>+7 days</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Methylene Blue MMX® 200mg</title>
            <description>Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule&#xD;
Methylene Blue MMX®</description>
          </group>
          <group group_id="O2">
            <title>Methylene Blue MMX® 100mg</title>
            <description>Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule&#xD;
Methylene Blue MMX®&#xD;
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Oral dose, 8 Placebo tablets over a 4hr schedule&#xD;
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.</title>
          <description>Adenoma Detection Rate</description>
          <population>FAS</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="485"/>
                <count group_id="O2" value="241"/>
                <count group_id="O3" value="479"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.3"/>
                    <measurement group_id="O2" value="51.5"/>
                    <measurement group_id="O3" value="47.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Methylene Blue MMX® 200mg</title>
          <description>Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule&#xD;
Methylene Blue MMX®</description>
        </group>
        <group group_id="E2">
          <title>Methylene Blue MMX® 100mg</title>
          <description>Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule&#xD;
Methylene Blue MMX®&#xD;
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Oral dose, 8 Placebo tablets over a 4hr schedule&#xD;
Placebo: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="479"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="485"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="479"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>viral bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="485"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="479"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="234" subjects_at_risk="488"/>
                <counts group_id="E2" subjects_affected="102" subjects_at_risk="241"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="479"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>faeces discoloured</sub_title>
                <counts group_id="E1" events="95" subjects_affected="95" subjects_at_risk="488"/>
                <counts group_id="E2" events="43" subjects_affected="43" subjects_at_risk="241"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="479"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>chromaturia</sub_title>
                <counts group_id="E1" events="234" subjects_affected="234" subjects_at_risk="488"/>
                <counts group_id="E2" events="102" subjects_affected="102" subjects_at_risk="241"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="479"/>
              </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>Publications to be reviewed by sponsor prior to submission.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>R&amp;D Manager</name_or_title>
      <organization>Cosmo Technologies Ltd</organization>
      <phone>111111111 ext 11111</phone>
      <email>rjones@cosmopharma.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/NCT01694966
org study id: CB-17-01/06
secondary id: 2012-003983-32
nct id: NCT01694966
lead sponsor: 
has dmc: Yes
Evaluation of the histologically proven adenoma and carcinoma detection rate in patients
      undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with
      200 mg of Methylene Blue MMX® tablets.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Participant, Investigator)
measure: To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.
time frame: +7 days
description: Adenoma Detection Rate
arm group label: Methylene Blue MMX® 200mg
arm group type: Active Comparator
description: Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
arm group label: Methylene Blue MMX® 100mg
arm group type: Active Comparator
description: Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral dose, 8 Placebo tablets over a 4hr schedule
intervention type: Drug
intervention name: Methylene Blue MMX®
arm group label: Methylene Blue MMX® 100mg
arm group label: Methylene Blue MMX® 200mg
other name: Investigational Product: Methylene Blue MMX® modified release tablets
other name: Active Ingredient: Methylene Blue
intervention type: Drug
intervention name: Placebo
description: Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
arm group label: Methylene Blue MMX® 100mg
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alessandro Repici, MD
role: Principal Investigator
affiliation: Co-ordinating Investigator EU
last name: Michael Wallace, MD
role: Principal Investigator
affiliation: Co-ordinating Investigator US
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country: Belgium
country: Canada
country: Germany
country: Italy
country: Lithuania
country: Netherlands
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Methylene Blue
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 