<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/NCT01711437</url>
  </required_header>
  <id_info>
    <org_study_id>PEG-P2</org_study_id>
    <nct_id>NCT01711437</nct_id>
  </id_info>
  <brief_title>Different Bowel Preparations for Colonoscopy In Children</brief_title>
  <official_title>EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Policlinico Umberto I</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Policlinico Umberto I</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL&#xD;
      PREPARATIONS FOR COLONOSCOPY IN CHILDREN.&#xD;
&#xD;
      THE AIM OF THIS STUDY IS TO COMPARE THE OVERALL COLON CLEANSING&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COLONOSCOPY IS AN ESTABLISHED DIAGNOSTIC AND THERAPEUTIC TOOL IN A VARIETY OF&#xD;
      GASTROINTESTINAL TRACT CONDITION AFFECTING CHILDREN AND ADOLESCENTs. FOR EXAMPLE:&#xD;
      INFLAMMATORY BOWEL DISEASE, COLONIC POLYPS OR LOWER GASTROINTESTINAL TRACT BLEEDING.&#xD;
&#xD;
      THE IDEAL PREPARATION SHOULD BE OF LOW VOLUME, PALATABLE AND SUCCESSFUL IN COMPLETE COLON&#xD;
      CLEANOUT.&#xD;
&#xD;
      PRIMARY AIMS OF THIS WERE TO COMPARE THE EFFICACY AND ACCEPTANCE OF FOUR METHODS OF BOWEL&#xD;
      CLEANSING BEFORE COLONOSCOPY IN CHILDREN. SECONDARY AIMS WAS TO COMPARE THE SAFETY PROFILE OF&#xD;
      THIS METHODS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2011</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">September 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>Single Group Assignment</intervention_model>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy</measure>
    <time_frame>During the performance of colonoscopy</time_frame>
    <description>Preparation efficacy was evaluated by the blinded endoscopist according to the Boston Bowel Preparation scale (BBPS) consisting of four-point scoring system.&#xD;
The total score ranging from 0 to 9 was divided into four different classes: excellent cleansing (total score 8-9), good cleansing (total score 6-7), poor cleansing (total score 4-5) and inadequate cleansing (total score 0-3).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>safety</measure>
    <time_frame>4 days</time_frame>
    <description>Adverse events were assessed on the day of colonoscopy by direct questioning and by telephone interview 48-96 hours after colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical tolerabiity</measure>
    <time_frame>On the morning of colonoscopy, immediately before the procedure</time_frame>
    <description>Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>On the morning of colonoscopy, immediately before the procedure</time_frame>
    <description>Compliance was scored on a 3-point scale according to the percentage of drunk solution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>On the morning of colonoscopy, immediately before the procedure</time_frame>
    <description>The easiness of taking or swallowing the solution was graded according to the following scale: very severe distress = 4, severe distress = 3, moderate distress = 2, mild distress = 1, no distress = 0.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>PEG-S</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>polyethylene glycol 4000 solution with simethicon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEG-CS + Bisacodyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PEG-CS is a new sulphate-free iso-osmotic formulation of PEG-4000 with citrates and simethicone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEG-ASC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>picoprep</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sodium picosulphate plus magnesium oxide and citric acid</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PEG-4000 with citrates and simethicone</intervention_name>
    <description>1-4 bisacodyl 5-mg tablets (Lovoldyl) at 16:00, followed 2-3 hours later by 50 ml/kg (maximum 2 L) of PEG-CS solution. The patients were instructed to drink all solution in about 2-3 hours.</description>
    <arm_group_label>PEG-CS + Bisacodyl</arm_group_label>
    <other_name>lovol-esse</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>polyethylene glycol 4000 solution with simethicon</intervention_name>
    <description>patients received a polyethylene glycol 4000 solution with simethicon (Selg Esse) starting at 3:00 p.m. the day before the colonoscopy at a dose of 100 ml/Kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours.</description>
    <arm_group_label>PEG-S</arm_group_label>
    <other_name>selg-esse</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid</intervention_name>
    <description>patients received a polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid (Moviprep) a dose of 50 ml/Kg (maximum 2 L) with 25 ml/kg additional clear fluid after completing solution intake.</description>
    <arm_group_label>PEG-ASC</arm_group_label>
    <other_name>moviprep</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sodium picosulphate plus magnesium oxide and citric acid</intervention_name>
    <description>patients received two sachets of sodium picosulphate plus magnesium oxide and citric acid (Picoprep), each diluted in 150 ml of water, at 14:00 and 6 hours later in the evening prior to the colonoscopy. Intake of at least 40-50 ml/kg of clear fluids</description>
    <arm_group_label>picoprep</arm_group_label>
    <other_name>Picoprep</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing elective colonoscopy in our Institution between 2 and 18 years of&#xD;
             age were recruited for this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. requirement for urgent colonoscopy,&#xD;
&#xD;
          2. bowel obstruction,&#xD;
&#xD;
          3. known or suspected hypersensitivity to the active or other ingredients,&#xD;
&#xD;
          4. clinically significant electrolyte imbalance,&#xD;
&#xD;
          5. prior intestinal resection,&#xD;
&#xD;
          6. known metabolic, renal and cardiac disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dipartimento di pediatria e neuropsichiatria Policlinico umberto l &quot;università di roma la sapienza&quot;</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dipartimento di pediatria e neuropsichiatria Policlinico umberto l &quot;università di roma la sapienza&quot;</last_name>
      <phone>0649979326</phone>
      <email>giovanni.dinardo@uniroma1.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>November 5, 2012</last_update_submitted>
  <last_update_submitted_qc>November 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Policlinico Umberto I</investigator_affiliation>
    <investigator_full_name>Giovanni Di Nardo</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>colonoscopy</keyword>
  <keyword>colon cleansing</keyword>
  <keyword>children</keyword>
  <keyword>age 2 -18 years</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ascorbic Acid</mesh_term>
    <mesh_term>Simethicone</mesh_term>
    <mesh_term>Picosulfate sodium</mesh_term>
    <mesh_term>Magnesium Oxide</mesh_term>
    <mesh_term>Polyethylene glycol 3350</mesh_term>
    <mesh_term>Citric Acid</mesh_term>
    <mesh_term>Sodium Citrate</mesh_term>
    <mesh_term>Pharmaceutical Solutions</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/NCT01711437
org study id: PEG-P2
nct id: NCT01711437
lead sponsor: 
has dmc: Yes
THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL
      PREPARATIONS FOR COLONOSCOPY IN CHILDREN.

      THE AIM OF THIS STUDY IS TO COMPARE THE OVERALL COLON CLEANSING
COLONOSCOPY IS AN ESTABLISHED DIAGNOSTIC AND THERAPEUTIC TOOL IN A VARIETY OF
      GASTROINTESTINAL TRACT CONDITION AFFECTING CHILDREN AND ADOLESCENTs. FOR EXAMPLE:
      INFLAMMATORY BOWEL DISEASE, COLONIC POLYPS OR LOWER GASTROINTESTINAL TRACT BLEEDING.

      THE IDEAL PREPARATION SHOULD BE OF LOW VOLUME, PALATABLE AND SUCCESSFUL IN COMPLETE COLON
      CLEANOUT.

      PRIMARY AIMS OF THIS WERE TO COMPARE THE EFFICACY AND ACCEPTANCE OF FOUR METHODS OF BOWEL
      CLEANSING BEFORE COLONOSCOPY IN CHILDREN. SECONDARY AIMS WAS TO COMPARE THE SAFETY PROFILE OF
      THIS METHODS.
allocation: Randomized
intervention model: Single Group Assignment
masking: Single (Investigator)
measure: Efficacy
time frame: During the performance of colonoscopy
description: Preparation efficacy was evaluated by the blinded endoscopist according to the Boston Bowel Preparation scale (BBPS) consisting of four-point scoring system.
The total score ranging from 0 to 9 was divided into four different classes: excellent cleansing (total score 8-9), good cleansing (total score 6-7), poor cleansing (total score 4-5) and inadequate cleansing (total score 0-3).
measure: safety
time frame: 4 days
description: Adverse events were assessed on the day of colonoscopy by direct questioning and by telephone interview 48-96 hours after colonoscopy.
measure: clinical tolerabiity
time frame: On the morning of colonoscopy, immediately before the procedure
description: Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort
measure: Compliance
time frame: On the morning of colonoscopy, immediately before the procedure
description: Compliance was scored on a 3-point scale according to the percentage of drunk solution
measure: Acceptability
time frame: On the morning of colonoscopy, immediately before the procedure
description: The easiness of taking or swallowing the solution was graded according to the following scale: very severe distress = 4, severe distress = 3, moderate distress = 2, mild distress = 1, no distress = 0.
arm group label: PEG-S
arm group type: Experimental
description: polyethylene glycol 4000 solution with simethicon
arm group label: PEG-CS + Bisacodyl
arm group type: Experimental
description: PEG-CS is a new sulphate-free iso-osmotic formulation of PEG-4000 with citrates and simethicone
arm group label: PEG-ASC
arm group type: Experimental
description: polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid
arm group label: picoprep
arm group type: Experimental
description: sodium picosulphate plus magnesium oxide and citric acid
intervention type: Device
intervention name: PEG-4000 with citrates and simethicone
description: 1-4 bisacodyl 5-mg tablets (Lovoldyl) at 16:00, followed 2-3 hours later by 50 ml/kg (maximum 2 L) of PEG-CS solution. The patients were instructed to drink all solution in about 2-3 hours.
arm group label: PEG-CS + Bisacodyl
other name: lovol-esse
intervention type: Device
intervention name: polyethylene glycol 4000 solution with simethicon
description: patients received a polyethylene glycol 4000 solution with simethicon (Selg Esse) starting at 3:00 p.m. the day before the colonoscopy at a dose of 100 ml/Kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours.
arm group label: PEG-S
other name: selg-esse
intervention type: Device
intervention name: polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid
description: patients received a polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid (Moviprep) a dose of 50 ml/Kg (maximum 2 L) with 25 ml/kg additional clear fluid after completing solution intake.
arm group label: PEG-ASC
other name: moviprep
intervention type: Device
intervention name: sodium picosulphate plus magnesium oxide and citric acid
description: patients received two sachets of sodium picosulphate plus magnesium oxide and citric acid (Picoprep), each diluted in 150 ml of water, at 14:00 and 6 hours later in the evening prior to the colonoscopy. Intake of at least 40-50 ml/kg of clear fluids
arm group label: picoprep
other name: Picoprep
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Policlinico Umberto I
investigator full name: Giovanni Di Nardo
investigator title: MD
mesh term: Ascorbic Acid
mesh term: Simethicone
mesh term: Picosulfate sodium
mesh term: Magnesium Oxide
mesh term: Polyethylene glycol 3350
mesh term: Citric Acid
mesh term: Sodium Citrate
mesh term: Pharmaceutical Solutions