<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/NCT02980562</url>
  </required_header>
  <id_info>
    <org_study_id>Korea University preparation</org_study_id>
    <nct_id>NCT02980562</nct_id>
  </id_info>
  <brief_title>Comparison of Low Volume PEG-Asc and Lower Volume PEG-Asc With Bisacodyl</brief_title>
  <official_title>Comparison of a Split Dose Bowel Preparation With 2-L Polyethylene Glycol Plus Ascorbic Acid and 1-L Polyethylene Glycol Plus Ascorbic Acid and Bisacodyl Prior to Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korea University Anam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Korea University Anam Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently a low-volume polyethylene glycol containing ascorbic acid (PEG-Asc) formulation has&#xD;
      proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation.&#xD;
      However, currently available aqueous purgative formulations are poorly tolerated. The aim of&#xD;
      this study was to compare a split-dose 2-L PEG-Asc and a 1-L PEG-Asc with bisacodyl (10 mg)&#xD;
      formulation to determine the quality of bowel cleansing and patient tolerability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      - Study design A single center, randomized, comparative observer-blinded study was performed&#xD;
      from May 2015 to September 2015 at the Department of Gastroenterology and Digestive Endoscopy&#xD;
      at Korea University Anam Hospital (Seoul, Korea).&#xD;
&#xD;
      In total, 200 outpatients received lower volume 1-L PEG with ascorbic acid plus bisacodyl&#xD;
      (1L-PEG/AB) or low volume 2-L PEG with ascorbic acid (2L-PEG/A) in a 1:1 ratio.&#xD;
&#xD;
      At the time of registration, subjects were randomly allocated to either group. They were&#xD;
      randomized by a computer-generated list and were provided with written instructions. All&#xD;
      patients provided written informed consent.&#xD;
&#xD;
        -  Patients All patients between the ages of 20 and 75 years. Patients were excluded from&#xD;
           the analysis if they had known or suspected gastrointestinal obstruction, Ileus, severe&#xD;
           heart failure, uncontrolled hypertension (systolic pressure &gt; 170 mmHg, diastolic&#xD;
           pressure &gt; 100 mmHg), severe constipation, clinically significant electrolyte&#xD;
           abnormalities, any prior bowel resection, or significant gastroparesis.&#xD;
&#xD;
        -  Bowel preparation In the 2L-PEG/A group, 1 L of PEG containing ascorbic acid was taken&#xD;
           at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The&#xD;
           second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy&#xD;
           examination, with an additional 500 mL of water. Each liter of preparation and the extra&#xD;
           500 mL water had to be consumed within 2 h of the procedure.&#xD;
&#xD;
      The 1L-PEG/AB group received 10 mg bisacodyl at 9:00 pm on the day before the colonoscopy.&#xD;
      Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was taken,&#xD;
      followed by an additional 1 L of water. The preparation was completed 2 h before the&#xD;
      examination. All colonoscopies were performed between 9 am and 1 pm.&#xD;
&#xD;
      - Assessment by endoscopists Colonoscopies were performed by two expert endoscopists who were&#xD;
      blinded to the preparation regimen. These two endoscopists worked for more than 5 years at&#xD;
      our institution.&#xD;
&#xD;
      Bowel cleansing was scored by the same endoscopist performing the colonoscopy. To assess the&#xD;
      cleansing quality of the bowel preparations, the Boston Bowel Preparation Scale (BBPS) and&#xD;
      the Aronchick Bowel Preparation Scale (ABPS) were used.&#xD;
&#xD;
      - Assessment of patient tolerability and adverse events Before the colonoscopy procedure,&#xD;
      patients completed questionnaires about their symptoms associated with the preparations to&#xD;
      assess tolerability. Patients were asked to assess the degree of abdominal fullness,&#xD;
      abdominal pain, nausea, vomiting, sleep disturbances, and general discomfort using a 5-point&#xD;
      scale (i.e., none, mild, moderate, severe, or very severe).&#xD;
&#xD;
      The palatability of the preparation was graded in 5 categories: very good, good, acceptable,&#xD;
      disgusting, and bad.&#xD;
&#xD;
      - Sample size and statistical analysis A sample size of at least 89 patients group was&#xD;
      required for each treatment group to detect a difference in treatment success of a 5% type-I&#xD;
      error rate and 80% power for a two-tailed χ2 test. Our sample size was based on the results&#xD;
      from a pilot study that was conducted in our hospital and included 35 patients in each group.&#xD;
      It was estimated that the efficacy for excellent treatment success would be 49% with PEG-2L/A&#xD;
      and 30% with PEG-1L/AB. Based on these data, we decided to collect 100 patients per treatment&#xD;
      group for study.&#xD;
&#xD;
      Continuous variables were expressed as mean ± standard deviation (SD), and discontinuous&#xD;
      variables were expressed as counts and percentages. SPSS 20.0 for Windows (SPSS Inc.,&#xD;
      Chicago, IL, US) was used for data entry and statistical analyses. For the analyses between&#xD;
      the two treatment groups, Students t-test as appropriate was used to compare continuous&#xD;
      variables and either the Chi-square or Fisher's exact test were used for categorical data.&#xD;
      The p-values &lt; 0.05 were considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The quality of the bowel preparation using preparation scale</measure>
    <time_frame>20 minutes</time_frame>
    <description>Preparation scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The patient's tolerability</measure>
    <time_frame>30 minutes before the colonoscopy</time_frame>
    <description>Patients were asked with questionnaires about the symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Bowel Disease</condition>
  <condition>Colon Adenoma</condition>
  <arm_group>
    <arm_group_label>2L Polyethylene glycols-Asc</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 L of PEG containing ascorbic acid (PEG A) was taken at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy examination, with an additional 500 mL of water. Each liter of preparation and the extra 500 mL water had to be consumed within 2 h of the procedure. All colonoscopies were performed between 9 am and 1 pm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1L PEG-Asc plus bisacodyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg bisacodyl at 9:00 pm on the day before the colonoscopy. Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was taken, followed by an additional 1 L of water. The preparation was completed 2 h before the examination. All colonoscopies were performed between 9 am and 1 pm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polyethylene Glycols</intervention_name>
    <description>(Split dose 2L PEG-Asc)</description>
    <arm_group_label>2L Polyethylene glycols-Asc</arm_group_label>
    <other_name>Coolprep®; Taejoon Pharmaceuticals, Seoul, Korea</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bisacodyl</intervention_name>
    <description>(1L PEG-Asc plus bisacodyl)</description>
    <arm_group_label>1L PEG-Asc plus bisacodyl</arm_group_label>
    <other_name>Coolprep®; Taejoon Pharmaceuticals, Seoul, Korea</other_name>
    <other_name>Dulcorax-S®; Boehringer Ingelheim, Seoul, Korea</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients between the ages of 20 and 75 years who were scheduled to undergo&#xD;
             colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  aged more than 75 years.&#xD;
&#xD;
          -  known or suspected gastrointestinal obstruction, Ileus&#xD;
&#xD;
          -  severe heart failure&#xD;
&#xD;
          -  uncontrolled hypertension (systolic pressure &gt; 170 mmHg, diastolic pressure &gt; 100&#xD;
             mmHg)&#xD;
&#xD;
          -  severe constipation&#xD;
&#xD;
          -  clinically significant electrolyte abnormalities&#xD;
&#xD;
          -  any prior bowel resection, or significant gastroparesis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yoon Tae Jeen</last_name>
    <role>Study Director</role>
    <affiliation>Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Seung Hun Kang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Korea University Anam Hospital</investigator_affiliation>
    <investigator_full_name>Seung Hun Kang</investigator_full_name>
    <investigator_title>Fellow</investigator_title>
  </responsible_party>
  <keyword>Bowel preparation</keyword>
  <keyword>Ascorbic acid</keyword>
  <keyword>Bisacodyl</keyword>
  <keyword>Polyethylene glycol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
  </condition_browse>
  <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/NCT02980562
org study id: Korea University preparation
nct id: NCT02980562
lead sponsor: 
has dmc: Yes
Recently a low-volume polyethylene glycol containing ascorbic acid (PEG-Asc) formulation has
      proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation.
      However, currently available aqueous purgative formulations are poorly tolerated. The aim of
      this study was to compare a split-dose 2-L PEG-Asc and a 1-L PEG-Asc with bisacodyl (10 mg)
      formulation to determine the quality of bowel cleansing and patient tolerability.
- Study design A single center, randomized, comparative observer-blinded study was performed
      from May 2015 to September 2015 at the Department of Gastroenterology and Digestive Endoscopy
      at Korea University Anam Hospital (Seoul, Korea).

      In total, 200 outpatients received lower volume 1-L PEG with ascorbic acid plus bisacodyl
      (1L-PEG/AB) or low volume 2-L PEG with ascorbic acid (2L-PEG/A) in a 1:1 ratio.

      At the time of registration, subjects were randomly allocated to either group. They were
      randomized by a computer-generated list and were provided with written instructions. All
      patients provided written informed consent.

        -  Patients All patients between the ages of 20 and 75 years. Patients were excluded from
           the analysis if they had known or suspected gastrointestinal obstruction, Ileus, severe
           heart failure, uncontrolled hypertension (systolic pressure > 170 mmHg, diastolic
           pressure > 100 mmHg), severe constipation, clinically significant electrolyte
           abnormalities, any prior bowel resection, or significant gastroparesis.

        -  Bowel preparation In the 2L-PEG/A group, 1 L of PEG containing ascorbic acid was taken
           at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The
           second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy
           examination, with an additional 500 mL of water. Each liter of preparation and the extra
           500 mL water had to be consumed within 2 h of the procedure.

      The 1L-PEG/AB group received 10 mg bisacodyl at 9:00 pm on the day before the colonoscopy.
      Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was taken,
      followed by an additional 1 L of water. The preparation was completed 2 h before the
      examination. All colonoscopies were performed between 9 am and 1 pm.

      - Assessment by endoscopists Colonoscopies were performed by two expert endoscopists who were
      blinded to the preparation regimen. These two endoscopists worked for more than 5 years at
      our institution.

      Bowel cleansing was scored by the same endoscopist performing the colonoscopy. To assess the
      cleansing quality of the bowel preparations, the Boston Bowel Preparation Scale (BBPS) and
      the Aronchick Bowel Preparation Scale (ABPS) were used.

      - Assessment of patient tolerability and adverse events Before the colonoscopy procedure,
      patients completed questionnaires about their symptoms associated with the preparations to
      assess tolerability. Patients were asked to assess the degree of abdominal fullness,
      abdominal pain, nausea, vomiting, sleep disturbances, and general discomfort using a 5-point
      scale (i.e., none, mild, moderate, severe, or very severe).

      The palatability of the preparation was graded in 5 categories: very good, good, acceptable,
      disgusting, and bad.

      - Sample size and statistical analysis A sample size of at least 89 patients group was
      required for each treatment group to detect a difference in treatment success of a 5% type-I
      error rate and 80% power for a two-tailed χ2 test. Our sample size was based on the results
      from a pilot study that was conducted in our hospital and included 35 patients in each group.
      It was estimated that the efficacy for excellent treatment success would be 49% with PEG-2L/A
      and 30% with PEG-1L/AB. Based on these data, we decided to collect 100 patients per treatment
      group for study.

      Continuous variables were expressed as mean ± standard deviation (SD), and discontinuous
      variables were expressed as counts and percentages. SPSS 20.0 for Windows (SPSS Inc.,
      Chicago, IL, US) was used for data entry and statistical analyses. For the analyses between
      the two treatment groups, Students t-test as appropriate was used to compare continuous
      variables and either the Chi-square or Fisher's exact test were used for categorical data.
      The p-values < 0.05 were considered statistically significant.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Investigator)
measure: The quality of the bowel preparation using preparation scale
time frame: 20 minutes
description: Preparation scale
measure: The patient's tolerability
time frame: 30 minutes before the colonoscopy
description: Patients were asked with questionnaires about the symptoms
arm group label: 2L Polyethylene glycols-Asc
arm group type: Active Comparator
description: 1 L of PEG containing ascorbic acid (PEG A) was taken at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy examination, with an additional 500 mL of water. Each liter of preparation and the extra 500 mL water had to be consumed within 2 h of the procedure. All colonoscopies were performed between 9 am and 1 pm.
arm group label: 1L PEG-Asc plus bisacodyl
arm group type: Active Comparator
description: 10 mg bisacodyl at 9:00 pm on the day before the colonoscopy. Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was taken, followed by an additional 1 L of water. The preparation was completed 2 h before the examination. All colonoscopies were performed between 9 am and 1 pm.
intervention type: Drug
intervention name: Polyethylene Glycols
description: (Split dose 2L PEG-Asc)
arm group label: 2L Polyethylene glycols-Asc
other name: Coolprep®; Taejoon Pharmaceuticals, Seoul, Korea
intervention type: Drug
intervention name: Bisacodyl
description: (1L PEG-Asc plus bisacodyl)
arm group label: 1L PEG-Asc plus bisacodyl
other name: Coolprep®; Taejoon Pharmaceuticals, Seoul, Korea
other name: Dulcorax-S®; Boehringer Ingelheim, Seoul, Korea
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yoon Tae Jeen
role: Study Director
affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine
last name: Seung Hun Kang
role: Principal Investigator
affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine
responsible party type: Principal Investigator
investigator affiliation: Korea University Anam Hospital
investigator full name: Seung Hun Kang
investigator title: Fellow
mesh term: Adenoma
mesh term: Bisacodyl