<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/NCT01685853</url>
  </required_header>
  <id_info>
    <org_study_id>IEO S570 510</org_study_id>
    <secondary_id>2010-022967-37</secondary_id>
    <nct_id>NCT01685853</nct_id>
  </id_info>
  <brief_title>Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One</brief_title>
  <official_title>Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One. A Randomized, Observer-blind, Parallel Group, Comparative Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Institute of Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Institute of Oncology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study is intended to evaluate the effectiveness, tolerability, compliance, and&#xD;
      feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L&#xD;
      Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of&#xD;
      colonoscopy, vs the standard 4L split PEG solution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients will be informed about the aims, procedures, benefits and possible risks of&#xD;
      the study prior to sign the informed consent form from day -30 to day-3. They will provide&#xD;
      medical history and undergo a physical examination. Patients will be evaluated by a Physician&#xD;
      other than the blind Endoscopist. The same responsible person will instruct the patients&#xD;
      about administration procedures in both oral and written form. The patients will be assigned&#xD;
      to receive one of the dosing schedule bowel preparation according to a computer generated&#xD;
      block-randomisation list. Patients will take the study treatment at home according to the&#xD;
      given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will&#xD;
      be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation&#xD;
      taken by the patient. Completed colonoscopic exam will be performed with time recorded&#xD;
      (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about&#xD;
      safety, tolerability, overall acceptance and compliance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy</measure>
    <time_frame>20 min</time_frame>
    <description>Evaluation of the quality of bowel preparation according to the Ottawa Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>20 min</time_frame>
    <description>Evaluation of the mucosal visibility according to a 3 point scale (0-2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>20 min</time_frame>
    <description>Adenoma detection rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>24 hours</time_frame>
    <description>Recording of all adverse events occurred during the study by patient questioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability</measure>
    <time_frame>24 hours</time_frame>
    <description>rate of patients in the two groups who developed GI symptoms related to bowel preparation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>24 hours</time_frame>
    <description>willingness to repeat the preparation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>24 hours</time_frame>
    <description>rate of patient with intake of at least 75% of bowel preparation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>PEG 4 litres split</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Polyethylene glycol with electrolytes (PEG)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bisacodyl plus PEG-CS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bisacodyl plus PEG-CS: Bisacodyl plus Polyethylene glycol with citrate and simethicone (PEG-CS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bisacodyl plus PEG-CS</intervention_name>
    <description>the day before colonoscopy: 3-4 bisacodyl tablets (according to patient bowel habit) at bedtime&#xD;
the morning of colonoscopy: PEG-CS (2 litres) starting 5 hours before the exam</description>
    <arm_group_label>Bisacodyl plus PEG-CS</arm_group_label>
    <other_name>LOVOLdyl plus LOVOLesse</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEG 4 litres split</intervention_name>
    <description>the day before colonoscopy: 2 litres of PEG&#xD;
the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination</description>
    <arm_group_label>PEG 4 litres split</arm_group_label>
    <other_name>SELG 1000</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Out-patients undergoing a complete colonoscopy&#xD;
&#xD;
          -  Patient written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women or at a risk of becoming pregnant&#xD;
&#xD;
          -  Known or suspected gastrointestinal obstruction or perforation; toxic megacolon; major&#xD;
             colonic resection Known or suspected hypersensitivity to the active principle and/or&#xD;
             formulations' ingredients&#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>Cristiano Crosta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>European Institute of Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>European Institute of Oncology</name>
      <address>
        <city>Milan</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bisacodyl</mesh_term>
  </intervention_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/NCT01685853
org study id: IEO S570 510
secondary id: 2010-022967-37
nct id: NCT01685853
lead sponsor: 
has dmc: Yes
The present study is intended to evaluate the effectiveness, tolerability, compliance, and
      feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L
      Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of
      colonoscopy, vs the standard 4L split PEG solution.
Eligible patients will be informed about the aims, procedures, benefits and possible risks of
      the study prior to sign the informed consent form from day -30 to day-3. They will provide
      medical history and undergo a physical examination. Patients will be evaluated by a Physician
      other than the blind Endoscopist. The same responsible person will instruct the patients
      about administration procedures in both oral and written form. The patients will be assigned
      to receive one of the dosing schedule bowel preparation according to a computer generated
      block-randomisation list. Patients will take the study treatment at home according to the
      given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will
      be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation
      taken by the patient. Completed colonoscopic exam will be performed with time recorded
      (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about
      safety, tolerability, overall acceptance and compliance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Efficacy
time frame: 20 min
description: Evaluation of the quality of bowel preparation according to the Ottawa Scale
measure: Efficacy
time frame: 20 min
description: Evaluation of the mucosal visibility according to a 3 point scale (0-2)
measure: Efficacy
time frame: 20 min
description: Adenoma detection rate
measure: Safety
time frame: 24 hours
description: Recording of all adverse events occurred during the study by patient questioning
measure: Tolerability
time frame: 24 hours
description: rate of patients in the two groups who developed GI symptoms related to bowel preparation
measure: Acceptability
time frame: 24 hours
description: willingness to repeat the preparation
measure: Compliance
time frame: 24 hours
description: rate of patient with intake of at least 75% of bowel preparation
arm group label: PEG 4 litres split
arm group type: Active Comparator
description: Polyethylene glycol with electrolytes (PEG)
arm group label: Bisacodyl plus PEG-CS
arm group type: Experimental
description: Bisacodyl plus PEG-CS: Bisacodyl plus Polyethylene glycol with citrate and simethicone (PEG-CS)
intervention type: Drug
intervention name: Bisacodyl plus PEG-CS
description: the day before colonoscopy: 3-4 bisacodyl tablets (according to patient bowel habit) at bedtime
the morning of colonoscopy: PEG-CS (2 litres) starting 5 hours before the exam
arm group label: Bisacodyl plus PEG-CS
other name: LOVOLdyl plus LOVOLesse
intervention type: Drug
intervention name: PEG 4 litres split
description: the day before colonoscopy: 2 litres of PEG
the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination
arm group label: PEG 4 litres split
other name: SELG 1000
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Cristiano Crosta, MD
role: Principal Investigator
affiliation: European Institute of Oncology
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Bisacodyl