<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/NCT01685970</url>
  </required_header>
  <id_info>
    <org_study_id>HGI-2012-09</org_study_id>
    <nct_id>NCT01685970</nct_id>
  </id_info>
  <brief_title>Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy</brief_title>
  <acronym>SP2HP</acronym>
  <official_title>Comparison of Using the Same-day 2 Sachets Picosulfate Versus High Volume PEG Bowel Preparation for Afternoon Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inje University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel&#xD;
      preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance&#xD;
      patient tolerability and have similar bowel cleansing efficacy compared to standard method&#xD;
      using high volume split-dose PEG.&#xD;
&#xD;
      The investigators aimed to evaluate the efficacy and tolerability of bowel preparation&#xD;
      protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L)&#xD;
      split-dose for afternoon colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Split-dose PEG (4L) regimens is a standard regimen for bowel preparation because it has&#xD;
      better preparation quality and tolerability than single dose 4L PEG regimens. However,&#xD;
      although patients drink each 2L separately, the total volume of 4 L PEG is still quite&#xD;
      burdensome volume to ingest. In addition, in split dose method, night dose of day before the&#xD;
      procedure make patient to suffer from sleep disturbance because of frequent diarrhea and&#xD;
      abdominal discomfort.&#xD;
&#xD;
      The investigators aimed to evaluate the efficacy and tolerability of bowel preparation&#xD;
      protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L)&#xD;
      split-dose for afternoon colonoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">November 2012</completion_date>
  <primary_completion_date type="Anticipated">November 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>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of bowel preparation</measure>
    <time_frame>3 months</time_frame>
    <description>Quality of bowel preparation using Ottawa bowel preparation scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerability</measure>
    <time_frame>3 months</time_frame>
    <description>Tolerability of bowel preparation regimen is assessed by patient questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>High volume Split-dose PEG</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 sachets of picosulfate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High volume split-dose PEG</intervention_name>
    <description>High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy</description>
    <arm_group_label>High volume Split-dose PEG</arm_group_label>
    <other_name>Polyethylene glycol(Colyte)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2 sachets of picosulfate</intervention_name>
    <description>2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy</description>
    <arm_group_label>2 sachets of picosulfate</arm_group_label>
    <other_name>sodium picosulfate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult outpatients who undergo afternoon colonoscopy for screening, surveillance or&#xD;
             with symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  breast feeding,&#xD;
&#xD;
          -  prior history of surgical large bowel resection,&#xD;
&#xD;
          -  severe medical condition such as severe cardiac,&#xD;
&#xD;
          -  hepatic, or&#xD;
&#xD;
          -  renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)),&#xD;
&#xD;
          -  significant gastric paresis or gastric outlet obstruction or ileus,&#xD;
&#xD;
          -  known or suspected bowel obstruction or perforation,&#xD;
&#xD;
          -  drug addiction or major psychiatric illness,&#xD;
&#xD;
          -  allergy to PEG and refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tae Oh Kim, Ph D</last_name>
    <role>Study Director</role>
    <affiliation>Haeundae Paik Hospital, Inje University College of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tae Oh Kim, Ph D.</last_name>
    <phone>82-51-797-0658</phone>
    <phone_ext>0658</phone_ext>
    <email>kto0440@paik.ac.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eun Hee Seo, MD</last_name>
    <phone>82-51-797-0220</phone>
    <phone_ext>0220</phone_ext>
    <email>arate98@naver.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Haeundae Paik Hospital, Inje University College of Medicine</name>
      <address>
        <city>Busan</city>
        <zip>612-030</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eun Hee Seo, MD</last_name>
      <phone>82-51-797-0220</phone>
      <phone_ext>0220</phone_ext>
      <email>arate98@naver.com</email>
    </contact>
    <contact_backup>
      <last_name>Tae Oh Kim, Ph D</last_name>
      <phone>52-51-797-0658</phone>
      <phone_ext>0658</phone_ext>
      <email>kto0440@paik.ac.kr</email>
    </contact_backup>
    <investigator>
      <last_name>Eun Hee Seo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>September 14, 2012</last_update_submitted>
  <last_update_submitted_qc>September 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inje University</investigator_affiliation>
    <investigator_full_name>Eun Hee Seo, MD</investigator_full_name>
    <investigator_title>Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for aternoon colonoscopy</investigator_title>
  </responsible_party>
  <keyword>Bowel preparation</keyword>
  <keyword>colonoscopy</keyword>
  <keyword>polyethylene glycol</keyword>
  <keyword>picosulfate</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Picosulfate sodium</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/NCT01685970
org study id: HGI-2012-09
nct id: NCT01685970
lead sponsor: 
has dmc: Yes
Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel
      preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance
      patient tolerability and have similar bowel cleansing efficacy compared to standard method
      using high volume split-dose PEG.

      The investigators aimed to evaluate the efficacy and tolerability of bowel preparation
      protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L)
      split-dose for afternoon colonoscopy.
Split-dose PEG (4L) regimens is a standard regimen for bowel preparation because it has
      better preparation quality and tolerability than single dose 4L PEG regimens. However,
      although patients drink each 2L separately, the total volume of 4 L PEG is still quite
      burdensome volume to ingest. In addition, in split dose method, night dose of day before the
      procedure make patient to suffer from sleep disturbance because of frequent diarrhea and
      abdominal discomfort.

      The investigators aimed to evaluate the efficacy and tolerability of bowel preparation
      protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L)
      split-dose for afternoon colonoscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Quality of bowel preparation
time frame: 3 months
description: Quality of bowel preparation using Ottawa bowel preparation scale
measure: Tolerability
time frame: 3 months
description: Tolerability of bowel preparation regimen is assessed by patient questionnaire.
arm group label: High volume Split-dose PEG
arm group type: Placebo Comparator
description: Patients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation
arm group label: 2 sachets of picosulfate
arm group type: Active Comparator
description: Patients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy.
intervention type: Drug
intervention name: High volume split-dose PEG
description: High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy
arm group label: High volume Split-dose PEG
other name: Polyethylene glycol(Colyte)
intervention type: Drug
intervention name: 2 sachets of picosulfate
description: 2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy
arm group label: 2 sachets of picosulfate
other name: sodium picosulfate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Tae Oh Kim, Ph D
role: Study Director
affiliation: Haeundae Paik Hospital, Inje University College of Medicine
last name: Tae Oh Kim, Ph D.
phone: 82-51-797-0658
phone ext: 0658
email: kto0440@paik.ac.kr
last name: Eun Hee Seo, MD
phone: 82-51-797-0220
phone ext: 0220
email: arate98@naver.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Inje University
investigator full name: Eun Hee Seo, MD
investigator title: Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for aternoon colonoscopy
mesh term: Picosulfate sodium