<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/NCT01689792</url>
  </required_header>
  <id_info>
    <org_study_id>NOR-01/2011 (PDR)</org_study_id>
    <nct_id>NCT01689792</nct_id>
  </id_info>
  <brief_title>A Multi-centre Study Comparing the Polyp Detection Rate of Two Different Types of Bowel Preparation: a 2-litre Solution (MOVIPREP®) Versus a Hyperosmotic and Stimulant Combined Low Volume Bowel Preparation (Sodium Picosulfate and Magnesium Citrate)</brief_title>
  <official_title>A Multi-centre, Randomised, Investigator-blinded Study Comparing the Polyp Detection Rate of Two Different Types of Bowel Preparation: a 2-litre Solution (MOVIPREP®) Versus a Hyperosmotic and Stimulant Combined Low Volume Bowel Preparation (Sodium Picosulfate and Magnesium Citrate)</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>
      To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium&#xD;
      Picosulfate/Magnesium Citrate solution.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 4</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>Polyp detection rate</measure>
    <time_frame>At colonoscopy</time_frame>
    <description>Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adenoma Detection Rate (ADR)</measure>
    <time_frame>At the Colonoscopy</time_frame>
    <description>ADR, (including flat lesions) defined as number of patients with at least one adenoma as recorded by the pathologist in relation to the total analysis population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADR and PDR by location</measure>
    <time_frame>at the colonoscopy</time_frame>
    <description>ADR and PDR by location:&#xD;
left sided (rectum, colon sigmoideum, colon decendens, left half of colon transversum&#xD;
right-sided (right half of colon transversum, colon ascendens, caecum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer detection rate</measure>
    <time_frame>at the colonoscopy</time_frame>
    <description>Cancer detection rate, defined as number of patients with at least one malignancy in relation to the total analysis population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flat lesion only detection rate</measure>
    <time_frame>at the colonoscopy</time_frame>
    <description>Flat lesion only detection of the patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Advanced risk lesion detection rate</measure>
    <time_frame>at the colonoscopy</time_frame>
    <description>Advanced risk lesion detection rate (lesions &gt;1 cm, low grade and/or villous</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Colonoscopy completion rate</measure>
    <time_frame>at the colonoscopy</time_frame>
    <description>The rate of colonoscopy completion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Colon cleansing quality</measure>
    <time_frame>at the colonoscopy</time_frame>
    <description>Colon cleansing quality as reported by the gastroenterologist, according to the Harefield Cleansing Scale©</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability and tolerability of medication using patient questionnaires</measure>
    <time_frame>Throughout the study</time_frame>
    <description>The acceptability and tolerability of the study medication taken by the patients throughout the study using specified patient questionnaires</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">398</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>CitraFleet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of CitraFleet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MOVIPREP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of MOVIPREP</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MOVIPREP</intervention_name>
    <arm_group_label>MOVIPREP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CitraFleet</intervention_name>
    <arm_group_label>CitraFleet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient's written informed consent must be obtained prior to inclusion.&#xD;
&#xD;
          -  Male or female outpatients or inpatients aged 40 to 80 years with an indication for&#xD;
             complete colonoscopy.&#xD;
&#xD;
          -  Willing to undergo a colonoscopy for diagnostic or surveillance purposes&#xD;
&#xD;
          -  Patients with a known personal of familial risk of colon neoplasia, willing to undergo&#xD;
             a screening colonoscopy&#xD;
&#xD;
          -  Willing, able and competent to complete the entire procedure and to comply with study&#xD;
             instructions.&#xD;
&#xD;
          -  Females of childbearing potential must employ an adequate method of contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of gastric emptying disorders.&#xD;
&#xD;
          -  History of ileus, toxic megacolon, gastrointestinal obstruction and colonic&#xD;
             perforation.&#xD;
&#xD;
          -  History of phenylketonuria.&#xD;
&#xD;
          -  Known glucose-6-phosphate dehydrogenase deficiency.&#xD;
&#xD;
          -  Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/sodium&#xD;
             ascorbate.&#xD;
&#xD;
          -  History of colonic resection.&#xD;
&#xD;
          -  Requirement for permanent medication and associated stable serum concentrations (e.g.&#xD;
             neuroleptic drugs).&#xD;
&#xD;
          -  Presence of congestive heart failure (NYHA III + IV).&#xD;
&#xD;
          -  Acute life-threatening cardiovascular disease.&#xD;
&#xD;
          -  Documented history of severe renal insufficiency (creatinine clearance &lt;30 ml/min).&#xD;
&#xD;
          -  Other contraindication described in the summary of product characteristics (SmPC) of&#xD;
             either preparation.&#xD;
&#xD;
          -  Patient has a condition, clinically significant laboratory results, or is in a&#xD;
             situation which, in the investigator's opinion, may put the patient at significant&#xD;
             risk, may confound the study results, or may interfere significantly.&#xD;
&#xD;
          -  Application of any unlicensed medication within the previous 3 months or participation&#xD;
             in any other research study in the last 3 months.&#xD;
&#xD;
          -  Females who are pregnant, nursing or planning a pregnancy.&#xD;
&#xD;
          -  Patients who, in the opinion of the investigator, may not be compliant with the study&#xD;
             requirements.&#xD;
&#xD;
          -  Previous participation in this clinical study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wolfgang Fishbach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum Aschaffenburg-Alzenau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum Aschaffenburg</name>
      <address>
        <city>Aschaffenburg</city>
        <zip>Am Hasenkopf 1</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2015</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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01689792
org study id: NOR-01/2011 (PDR)
nct id: NCT01689792
lead sponsor: 
has dmc: No
To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium
      Picosulfate/Magnesium Citrate solution.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Investigator)
measure: Polyp detection rate
time frame: At colonoscopy
description: Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist
measure: Adenoma Detection Rate (ADR)
time frame: At the Colonoscopy
description: ADR, (including flat lesions) defined as number of patients with at least one adenoma as recorded by the pathologist in relation to the total analysis population
measure: ADR and PDR by location
time frame: at the colonoscopy
description: ADR and PDR by location:
left sided (rectum, colon sigmoideum, colon decendens, left half of colon transversum
right-sided (right half of colon transversum, colon ascendens, caecum
measure: Cancer detection rate
time frame: at the colonoscopy
description: Cancer detection rate, defined as number of patients with at least one malignancy in relation to the total analysis population
measure: Flat lesion only detection rate
time frame: at the colonoscopy
description: Flat lesion only detection of the patients
measure: Advanced risk lesion detection rate
time frame: at the colonoscopy
description: Advanced risk lesion detection rate (lesions >1 cm, low grade and/or villous
measure: Colonoscopy completion rate
time frame: at the colonoscopy
description: The rate of colonoscopy completion
measure: Colon cleansing quality
time frame: at the colonoscopy
description: Colon cleansing quality as reported by the gastroenterologist, according to the Harefield Cleansing Scale©
measure: Acceptability and tolerability of medication using patient questionnaires
time frame: Throughout the study
description: The acceptability and tolerability of the study medication taken by the patients throughout the study using specified patient questionnaires
arm group label: CitraFleet
arm group type: Active Comparator
description: Administration of CitraFleet
arm group label: MOVIPREP
arm group type: Experimental
description: Administration of MOVIPREP
intervention type: Drug
intervention name: MOVIPREP
arm group label: MOVIPREP
intervention type: Drug
intervention name: CitraFleet
arm group label: CitraFleet
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wolfgang Fishbach, MD
role: Principal Investigator
affiliation: Klinikum Aschaffenburg-Alzenau
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Colorectal Neoplasms