<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/NCT02979223</url>
  </required_header>
  <id_info>
    <org_study_id>NCC2016-0166</org_study_id>
    <nct_id>NCT02979223</nct_id>
  </id_info>
  <brief_title>Combination Method Using Sodium Picosulfate and Magnesium Citrate and PEG With Ascorbic Acid for Bowel Preparation</brief_title>
  <official_title>Comparison the Efficacy Depending on the Order of the Sequential Combination Method Using Sodium Picosulfate and Magnesium Citrate (PMC) and PEG With Ascorbic Acid for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Center, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Center, Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the efficacy depending on the order of the sequential&#xD;
      combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with ascorbic&#xD;
      acid for bowel preparation.&#xD;
&#xD;
      The investigators designed this study as a phase II prospective randomized parallel arm&#xD;
      clinical trial. 71 participant will be enrolled in each group (142 in total).&#xD;
&#xD;
      The primary outcome is the efficacy of bowel preparation. secondary outcomes are&#xD;
      tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 2</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>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful bowel preparation (Excellent and Good in Aronchick bowel preparation score)</measure>
    <time_frame>during colonoscopy</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">142</enrollment>
  <condition>Bowel Preparation</condition>
  <condition>Sodium Picosulfate and Magnesium Citrate</condition>
  <condition>Polyethylene Glycol With Ascorbic Acid</condition>
  <arm_group>
    <arm_group_label>PMC/PEG-Asc</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Picolyte 1 bottle/170cc at one day before colonoscopy, 7 PM. And then, Intake Coolprep 1L at the day of colonoscopy, 5 AM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEG-Asc/PMC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intake Coolprep 1L at one day before colonoscopy, 7 PM. And then, Intake Picolyte 1 bottle/170cc at the day of colonoscopy, 5AM</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid</intervention_name>
    <description>sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method.&#xD;
There is a difference in the order of intake between two group</description>
    <arm_group_label>PEG-Asc/PMC</arm_group_label>
    <arm_group_label>PMC/PEG-Asc</arm_group_label>
    <other_name>Picosolution</other_name>
    <other_name>Coolprep</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 20-75 Patients who visited the outpatient clinic for colonoscopy Patients who&#xD;
             agreed to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy, breast feeding stage 3-5 chronic kidney disease (glomerular filtration rate&#xD;
             &lt; 60 mL/min/1.73m2), inability to maintain adequate fluid intake, pre-existing&#xD;
             electrolyte disturbances, symptomatic congestive heart failure, recent (within &lt; 6&#xD;
             months) symptomatic ischemic heart disease (unstable angina or myocardial infarction).&#xD;
&#xD;
        toxic megacolon active colitis Allergic to drug altered mental status Nausea and vomiting&#xD;
        Hyperphosphatemia glucose-6-phosphate dehydrogenase deficiency Hereditary Phenylketonuria&#xD;
        Patients with a history of colon surgery Abdominal operation within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bun Kim, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center, Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bun Kim</name>
      <address>
        <city>Goyang</city>
        <state>Gyeonggi-do</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>August 22, 2019</last_update_submitted>
  <last_update_submitted_qc>August 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Center, Korea</investigator_affiliation>
    <investigator_full_name>Byung Chang KIM</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ascorbic Acid</mesh_term>
    <mesh_term>Magnesium citrate</mesh_term>
    <mesh_term>Picosulfate sodium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02979223
org study id: NCC2016-0166
nct id: NCT02979223
lead sponsor: 
has dmc: No
The aim of this study is to compare the efficacy depending on the order of the sequential
      combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with ascorbic
      acid for bowel preparation.

      The investigators designed this study as a phase II prospective randomized parallel arm
      clinical trial. 71 participant will be enrolled in each group (142 in total).

      The primary outcome is the efficacy of bowel preparation. secondary outcomes are
      tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Successful bowel preparation (Excellent and Good in Aronchick bowel preparation score)
time frame: during colonoscopy
arm group label: PMC/PEG-Asc
arm group type: Experimental
description: Picolyte 1 bottle/170cc at one day before colonoscopy, 7 PM. And then, Intake Coolprep 1L at the day of colonoscopy, 5 AM
arm group label: PEG-Asc/PMC
arm group type: Active Comparator
description: Intake Coolprep 1L at one day before colonoscopy, 7 PM. And then, Intake Picolyte 1 bottle/170cc at the day of colonoscopy, 5AM
intervention type: Drug
intervention name: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid
description: sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method.
There is a difference in the order of intake between two group
arm group label: PEG-Asc/PMC
arm group label: PMC/PEG-Asc
other name: Picosolution
other name: Coolprep
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bun Kim, Dr
role: Principal Investigator
affiliation: National Cancer Center, Korea
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: National Cancer Center, Korea
investigator full name: Byung Chang KIM
investigator title: Principle investigator
mesh term: Ascorbic Acid
mesh term: Magnesium citrate
mesh term: Picosulfate sodium
sharing ipd: No