<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/NCT02248337</url>
  </required_header>
  <id_info>
    <org_study_id>LOVOL-IBD</org_study_id>
    <nct_id>NCT02248337</nct_id>
  </id_info>
  <brief_title>Low Volume Colon Preparation for IBD</brief_title>
  <official_title>Colon Cleasing for Colonoscopy in Patients With IBD Colitis: Efficacy and Acceptability of 4 Liter PEG vs 2 Liter PEG Plus Bisacodil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Luigi Sacco University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Luigi Sacco University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low-volume preparations are gaining attention for higher acceptability. This study compares&#xD;
      efficacy, safety and tolerability of a 2L PEG solution plus bisacodil with a 4L PEG solution&#xD;
      in patients with inflammatory bowel disease-related colitis.&#xD;
&#xD;
      This will be a multicenter, randomized, single-blind study. Adult outpatients with IBD&#xD;
      colitis undergoing colonoscopy will receive either 2L PEG plus biscodil or 4L PEG. Bowel&#xD;
      cleansing will be assessed using the Ottawa Scale and rated as adequate if &lt;6. Patient&#xD;
      acceptance, satisfaction, and related symptoms will be also recorded. The study will also&#xD;
      focus on the factors affecting quality of preparation in inflammatory bowel disease patients&#xD;
      such as disease characteristics and administration regimen&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">December 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>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy</measure>
    <time_frame>During endoscopy within 24 hours after preparation</time_frame>
    <description>Quality of colon cleansing assesse with Ottawa bowel preparation score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>during product assumption</time_frame>
    <description>Intake of at least 75% of the product volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tollerability</measure>
    <time_frame>during product assumption</time_frame>
    <description>Occurrence of discomfort during drug intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety</measure>
    <time_frame>From drug intake to the end of colonoscopy</time_frame>
    <description>Occurrence of side effects</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">216</enrollment>
  <condition>Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>4 Liter PEG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Colon preparation for colonoscopy: PEG 4 Liter before endoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 Liter PEG plus bisacodil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Colon preparation for colonoscopy: PEG 2 L before endoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Colon preparation for colonoscopy</intervention_name>
    <description>Colon cleansing prior to perform colonoscopy</description>
    <arm_group_label>2 Liter PEG plus bisacodil</arm_group_label>
    <arm_group_label>4 Liter PEG</arm_group_label>
    <other_name>Colon cleansing</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Adult outpatiets with IBD colitis undergoing colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous colon resection, ileus, intestinal obstruction, toxic megacolon, severe heart&#xD;
             failure (NYHA Class III or IV), acute cardiovascular disease, uncontrolled arterial&#xD;
             hypertension (systolic pressure &gt;170 mmHg, diastolic pressure &gt;100 mmHg), severe liver&#xD;
             cirrhosis (Child-Pugh score C) or renal failure (creatinine clearance&lt;30 mL/minute),&#xD;
             ascites, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency&#xD;
&#xD;
          -  Pregnant or breastfeeding women were also excluded&#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>gianpiero manes, MD</last_name>
    <role>Study Chair</role>
    <affiliation>AO G. Salvini Garbagnate Milanes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Luigi Sacco University Hospital</name>
      <address>
        <city>Milano</city>
        <zip>I-20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 23, 2014</last_update_submitted>
  <last_update_submitted_qc>September 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Luigi Sacco University Hospital</investigator_affiliation>
    <investigator_full_name>Gianpiero Manes</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Colon preparation; Colonoscopy; Inflammatory bowel disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</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/NCT02248337
org study id: LOVOL-IBD
nct id: NCT02248337
lead sponsor: 
has dmc: No
Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel
      disease.
Low-volume preparations are gaining attention for higher acceptability. This study compares
      efficacy, safety and tolerability of a 2L PEG solution plus bisacodil with a 4L PEG solution
      in patients with inflammatory bowel disease-related colitis.

      This will be a multicenter, randomized, single-blind study. Adult outpatients with IBD
      colitis undergoing colonoscopy will receive either 2L PEG plus biscodil or 4L PEG. Bowel
      cleansing will be assessed using the Ottawa Scale and rated as adequate if <6. Patient
      acceptance, satisfaction, and related symptoms will be also recorded. The study will also
      focus on the factors affecting quality of preparation in inflammatory bowel disease patients
      such as disease characteristics and administration regimen
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Efficacy
time frame: During endoscopy within 24 hours after preparation
description: Quality of colon cleansing assesse with Ottawa bowel preparation score
measure: Compliance
time frame: during product assumption
description: Intake of at least 75% of the product volume
measure: Tollerability
time frame: during product assumption
description: Occurrence of discomfort during drug intake
measure: safety
time frame: From drug intake to the end of colonoscopy
description: Occurrence of side effects
arm group label: 4 Liter PEG
arm group type: Active Comparator
description: Colon preparation for colonoscopy: PEG 4 Liter before endoscopy
arm group label: 2 Liter PEG plus bisacodil
arm group type: Experimental
description: Colon preparation for colonoscopy: PEG 2 L before endoscopy
intervention type: Drug
intervention name: Colon preparation for colonoscopy
description: Colon cleansing prior to perform colonoscopy
arm group label: 2 Liter PEG plus bisacodil
arm group label: 4 Liter PEG
other name: Colon cleansing
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: gianpiero manes, MD
role: Study Chair
affiliation: AO G. Salvini Garbagnate Milanes
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Luigi Sacco University Hospital
investigator full name: Gianpiero Manes
investigator title: MD
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases