<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/NCT04474002</url>
  </required_header>
  <id_info>
    <org_study_id>PICO-PEG trial</org_study_id>
    <nct_id>NCT04474002</nct_id>
  </id_info>
  <brief_title>Efficacy, Tolerance and Safety of Split Dose Bowel Preparation for Colonoscopy: 4L Polyethylene Glycol (PEG) Versus 1L Polyethylene Glycol Plus Sodium Picosulfate-magnesium Citrate (SPMC)</brief_title>
  <official_title>Efficacy, Tolerance and Safety of Split Dose Bowel Preparation for Colonoscopy: 4L Polyethylene Glycol (PEG) Versus 1L Polyethylene Glycol Plus Sodium Picosulfate-magnesium Citrate (SPMC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Elizabeth Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen Elizabeth Hospital, Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      4L split dose PEG is the gold standard for bowel preparation, however it comes with poor&#xD;
      tolerability and poor compliance. Combination of PEG with different agent is useful in&#xD;
      reducing total volume, improving compliance and tolerance of patient.&#xD;
&#xD;
      The objective of this study is to demonstrate that combination bowel preparation, PEG plus&#xD;
      SPMC solution, has similar efficacy and safety profile whereas with a better tolerance when&#xD;
      compared to large volume PEG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, single-center, single-blinded, non-inferiority trial.&#xD;
&#xD;
      Participants with out patient colonoscopy arranged will be included and randomized in a 1:1&#xD;
      ratio to receive either a split dose of 4L PEG + Electrolyte (Klean-prep® ) or 1L Klean-prep®&#xD;
      plus 2 sachets SPMC (Picoprep®).&#xD;
&#xD;
      Trained endoscopists will be using the Boston Bowel Preparation Scale (BBPS) to assess the&#xD;
      quality of bowel preparation. Patient would also rate the tolerance, compliance and adverse&#xD;
      effect by filling the questionnaire before the colonoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 7, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Boston Bowel Preparation Score (BBPS)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Adequate bowel preparation is defined as a total BPPS score &gt;/= 6 in which all three segments had score &gt;/=2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient tolerability to bowel preparation using Likert scale</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Patient are requested to fill in questionnaire on the day of colonoscopy. Candidate are asked to rate the frequency of complications between 'none', 'mild', 'moderate' and 'severe'. 'None' being the best outcome and 'severe' being the worst outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient compliance towards bowel preparation</measure>
    <time_frame>Till the day of procedure</time_frame>
    <description>Proportion of patient able to complete the whole bowel preparation as instructed by protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patient requiring repeat colonoscopy</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Proportion of incomplete colonoscopy due to inadequate bowel preparation Patient will be attended by physicians and blood taking will be arranged</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment related adverse events</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Patient will be monitored after colonoscopy for any complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">158</enrollment>
  <condition>Bowel Preparation Solutions</condition>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>4L Klean Prep®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl and aspartame 0.0494g</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1L Klean prep® and 2 sachets Picoprep®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl, aspartame 0.0494g, sodium picosulfate 0.01g, magnesium oxide 3.5g, citric acid 12.0g</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>4L Klean Prep®</intervention_name>
    <description>Patients allocated to the control group shall mix two sachets of PEG in 2L water. At 6pm the evening before examination, they shall consume 250ml solution every 15mins, and finish in 2hours. At 7am the day of examination, drink another 2L Klean-prep in 2 hours.</description>
    <arm_group_label>4L Klean Prep®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1L Klean prep® and 2 sachets Picoprep®</intervention_name>
    <description>Patients allocated to the study group shall mix each sachet of Picoprep® in 150ml warm water. The patient shall take the 1st dose at 4pm the day before procedure followed by at least five 250ml drinks of clear fluid before the next dose. The 2nd dose shall be taken approximately 6hrs later and followed by at least three 250ml drinks of clear fluid before bed. On 7am the day of procedure, they shall take 1L PEG in 1 hour.</description>
    <arm_group_label>1L Klean prep® and 2 sachets Picoprep®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient who mentally capable to consent for participating the trial&#xD;
&#xD;
          2. 18 - 65 years old&#xD;
&#xD;
          3. Scheduled for 1st colonoscopy&#xD;
&#xD;
          4. Elective outpatient colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior colorectal or abdominal-pelvic surgery&#xD;
&#xD;
          2. Inflammatory bowel disease&#xD;
&#xD;
          3. Active bowel condition eg intestinal obstruction&#xD;
&#xD;
          4. Gastrointestinal disorders eg active ulcer, gastric outlet obstruction, gastroparesis&#xD;
             and hypomotility syndrome&#xD;
&#xD;
          5. Recent myocardial infarction, congestive heart failure, uncontrolled hypertension&#xD;
&#xD;
          6. Renal dysfunction, hepatic disease&#xD;
&#xD;
          7. Patient on long term tranquilizer, anti-spasmodic, prokinetic, laxative or&#xD;
             antidiarrhoeal agents&#xD;
&#xD;
          8. Hypersensitivity to PEG or SPMC solution&#xD;
&#xD;
          9. Pregnant or breastfeeding women&#xD;
&#xD;
         10. Inability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yau Kan Tso</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Elizabeth Hospital, Hospital Authority</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yau Kan Tso</last_name>
    <phone>00852 35067479</phone>
    <email>tyk895@ha.org.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Kowloon</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yau Kan Tso</last_name>
      <phone>00852 35067479</phone>
      <email>tyk895@ha.org.hk</email>
    </contact>
    <investigator>
      <last_name>Yau Kan Tso</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>September 7, 2022</last_update_submitted>
  <last_update_submitted_qc>September 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen Elizabeth Hospital, Hong Kong</investigator_affiliation>
    <investigator_full_name>Tso Yau Kan</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <keyword>Polyethylene glycol</keyword>
  <keyword>Picoprep</keyword>
  <keyword>Cathartics</keyword>
  <keyword>Bowel preparation solution</keyword>
  <keyword>Colonoscopy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Picosulfate sodium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT04474002/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04474002
org study id: PICO-PEG trial
nct id: NCT04474002
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
4L split dose PEG is the gold standard for bowel preparation, however it comes with poor
      tolerability and poor compliance. Combination of PEG with different agent is useful in
      reducing total volume, improving compliance and tolerance of patient.

      The objective of this study is to demonstrate that combination bowel preparation, PEG plus
      SPMC solution, has similar efficacy and safety profile whereas with a better tolerance when
      compared to large volume PEG.
This is a prospective, randomized, single-center, single-blinded, non-inferiority trial.

      Participants with out patient colonoscopy arranged will be included and randomized in a 1:1
      ratio to receive either a split dose of 4L PEG + Electrolyte (Klean-prep® ) or 1L Klean-prep®
      plus 2 sachets SPMC (Picoprep®).

      Trained endoscopists will be using the Boston Bowel Preparation Scale (BBPS) to assess the
      quality of bowel preparation. Patient would also rate the tolerance, compliance and adverse
      effect by filling the questionnaire before the colonoscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Boston Bowel Preparation Score (BBPS)
time frame: Up to 24 weeks
description: Adequate bowel preparation is defined as a total BPPS score >/= 6 in which all three segments had score >/=2
measure: Patient tolerability to bowel preparation using Likert scale
time frame: Up to 24 weeks
description: Patient are requested to fill in questionnaire on the day of colonoscopy. Candidate are asked to rate the frequency of complications between 'none', 'mild', 'moderate' and 'severe'. 'None' being the best outcome and 'severe' being the worst outcome.
measure: Patient compliance towards bowel preparation
time frame: Till the day of procedure
description: Proportion of patient able to complete the whole bowel preparation as instructed by protocol
measure: Proportion of patient requiring repeat colonoscopy
time frame: Up to 24 weeks
description: Proportion of incomplete colonoscopy due to inadequate bowel preparation Patient will be attended by physicians and blood taking will be arranged
measure: Incidence of treatment related adverse events
time frame: Up to 24 weeks
description: Patient will be monitored after colonoscopy for any complications
arm group label: 4L Klean Prep®
arm group type: Active Comparator
description: Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl and aspartame 0.0494g
arm group label: 1L Klean prep® and 2 sachets Picoprep®
arm group type: Experimental
description: Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl, aspartame 0.0494g, sodium picosulfate 0.01g, magnesium oxide 3.5g, citric acid 12.0g
intervention type: Drug
intervention name: 4L Klean Prep®
description: Patients allocated to the control group shall mix two sachets of PEG in 2L water. At 6pm the evening before examination, they shall consume 250ml solution every 15mins, and finish in 2hours. At 7am the day of examination, drink another 2L Klean-prep in 2 hours.
arm group label: 4L Klean Prep®
intervention type: Drug
intervention name: 1L Klean prep® and 2 sachets Picoprep®
description: Patients allocated to the study group shall mix each sachet of Picoprep® in 150ml warm water. The patient shall take the 1st dose at 4pm the day before procedure followed by at least five 250ml drinks of clear fluid before the next dose. The 2nd dose shall be taken approximately 6hrs later and followed by at least three 250ml drinks of clear fluid before bed. On 7am the day of procedure, they shall take 1L PEG in 1 hour.
arm group label: 1L Klean prep® and 2 sachets Picoprep®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yau Kan Tso
role: Principal Investigator
affiliation: Queen Elizabeth Hospital, Hospital Authority
last name: Yau Kan Tso
phone: 00852 35067479
email: tyk895@ha.org.hk
facility: 
status: Recruiting
contact: 
investigator: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Queen Elizabeth Hospital, Hong Kong
investigator full name: Tso Yau Kan
investigator title: Resident
mesh term: Picosulfate sodium
sharing ipd: No
provided document: 