<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/NCT04504292</url>
  </required_header>
  <id_info>
    <org_study_id>21980</org_study_id>
    <nct_id>NCT04504292</nct_id>
  </id_info>
  <brief_title>Pilot Study to Assess Tolerability and Feasibility of Oral Sulfate Solution (SUPREP) in Hospitalized Patients</brief_title>
  <official_title>Pilot Study to Assess Tolerability and Feasibility of Oral Sulfate Solution (SUPREP) in Hospitalized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test the efficacy, tolerability, and feasibility of an oral sulfate solution&#xD;
      (SUPREP) for inpatient colonoscopy preparation, compared to the standard of care (GoLytely).&#xD;
      The hypothesis is that SUPREP will be well tolerated and non-inferior to standard&#xD;
      polyethylene glycol bowel preparation for colonoscopies in an inpatient setting. To test&#xD;
      this, at least 124 subjects who are undergoing an inpatient colonoscopy will be randomized to&#xD;
      receive either SUPREP or standard of care. The Boston Bowel Preparation Score will be&#xD;
      collected as standard of care for both groups. Safety will be monitored from standard of care&#xD;
      blood tests and ECG (when indicated). Subjects will be given a survey to assess how tolerable&#xD;
      they found the procedure.&#xD;
&#xD;
      A non-inferiority design will be used to compare SUPREP to the standard of care polyethylene&#xD;
      glycol preparation. Data analysis will be performed on Boston Bowel Preparation Score and&#xD;
      rate of failure of preparation (measured as number of successful subsequent colonoscopies).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2021</primary_completion_date>
  <phase>N/A</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Non-inferiority design to compare SUPREP to GoLytely (standard of care)</measure>
    <time_frame>6 months</time_frame>
    <description>Boston Bowel Preparation Score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Failure of performing colonoscopy</measure>
    <time_frame>6 months</time_frame>
    <description>Prep Adequacy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Inpatient Colonoscopy</condition>
  <condition>Oral Sulfate Solution</condition>
  <condition>Polyethelene Glycol</condition>
  <arm_group>
    <arm_group_label>Oral sulfate solution (SuPREP arm)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Per the package insert: The dose for colon cleansing requires administration of two bottles of SUPREP Bowel Prep Kit. Each bottle is administered as 16 oz of diluted SUPREP solution with an additional 1quart of water taken orally. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts (approximately 2.8 L) taken orally prior to the colonoscopy outlined below under frequency.&#xD;
Two 6 oz bottles of oral solution: Each 6 oz bottle contains: sodium sulfate 17.5 g, potassium sulfate 3.13 g, magnesium sulfate 1.6 g.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Polyethelene Glycol (GoLytely arm)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Polyethylene Glycol Bowel Prep Kit</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SUPREP Bowel Prep Kit</intervention_name>
    <description>Bowel prep prior to colonoscopy</description>
    <arm_group_label>Oral sulfate solution (SuPREP arm)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Golytely Oral Product</intervention_name>
    <description>Bowel prep prior to colonoscopy</description>
    <arm_group_label>Polyethelene Glycol (GoLytely arm)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients will be approached with consent for the study only if there is a clinical&#xD;
             indication for pursuing an inpatient colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to consent (patient or POA)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rohan Modi, MD</last_name>
    <phone>248-229-3907</phone>
    <email>modi@virginia.edu</email>
  </overall_contact>
  <reference>
    <citation>Lee HH, Lim CH, Kim JS, Cho YK, Lee BI, Cho YS, Lee IS, Choi MG. Comparison Between an Oral Sulfate Solution and a 2 L of Polyethylene Glycol/Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy. J Clin Gastroenterol. 2019 Nov/Dec;53(10):e431-e437. doi: 10.1097/MCG.0000000000001137.</citation>
    <PMID>30308546</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Vanessa Shami, MD</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <!-- 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/NCT04504292
org study id: 21980
nct id: NCT04504292
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will test the efficacy, tolerability, and feasibility of an oral sulfate solution
      (SUPREP) for inpatient colonoscopy preparation, compared to the standard of care (GoLytely).
      The hypothesis is that SUPREP will be well tolerated and non-inferior to standard
      polyethylene glycol bowel preparation for colonoscopies in an inpatient setting. To test
      this, at least 124 subjects who are undergoing an inpatient colonoscopy will be randomized to
      receive either SUPREP or standard of care. The Boston Bowel Preparation Score will be
      collected as standard of care for both groups. Safety will be monitored from standard of care
      blood tests and ECG (when indicated). Subjects will be given a survey to assess how tolerable
      they found the procedure.

      A non-inferiority design will be used to compare SUPREP to the standard of care polyethylene
      glycol preparation. Data analysis will be performed on Boston Bowel Preparation Score and
      rate of failure of preparation (measured as number of successful subsequent colonoscopies).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: Non-inferiority design to compare SUPREP to GoLytely (standard of care)
time frame: 6 months
description: Boston Bowel Preparation Score
measure: Failure of performing colonoscopy
time frame: 6 months
description: Prep Adequacy
arm group label: Oral sulfate solution (SuPREP arm)
arm group type: Experimental
description: Per the package insert: The dose for colon cleansing requires administration of two bottles of SUPREP Bowel Prep Kit. Each bottle is administered as 16 oz of diluted SUPREP solution with an additional 1quart of water taken orally. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts (approximately 2.8 L) taken orally prior to the colonoscopy outlined below under frequency.
Two 6 oz bottles of oral solution: Each 6 oz bottle contains: sodium sulfate 17.5 g, potassium sulfate 3.13 g, magnesium sulfate 1.6 g.
arm group label: Polyethelene Glycol (GoLytely arm)
arm group type: Active Comparator
description: Polyethylene Glycol Bowel Prep Kit
intervention type: Drug
intervention name: SUPREP Bowel Prep Kit
description: Bowel prep prior to colonoscopy
arm group label: Oral sulfate solution (SuPREP arm)
intervention type: Drug
intervention name: Golytely Oral Product
description: Bowel prep prior to colonoscopy
arm group label: Polyethelene Glycol (GoLytely arm)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Rohan Modi, MD
phone: 248-229-3907
email: modi@virginia.edu
citation: Lee HH, Lim CH, Kim JS, Cho YK, Lee BI, Cho YS, Lee IS, Choi MG. Comparison Between an Oral Sulfate Solution and a 2 L of Polyethylene Glycol/Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy. J Clin Gastroenterol. 2019 Nov/Dec;53(10):e431-e437. doi: 10.1097/MCG.0000000000001137.
PMID: 30308546
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Vanessa Shami, MD
investigator title: Professor of Medicine