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Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy

Primary Purpose

Colon Adenoma, Colonic Polyp

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CleanViewAL
SUPREP
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colon Adenoma

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult out clinic patients scheduled for colonoscopy for any indication within the normal process of care

Exclusion Criteria:

  • previous history of significant gastrointestinal surgeries (except for appendectomy)
  • known or clinically suspicious Inflammatory bowel disease patients
  • known or suspected ileus/ GI obstruction
  • previous history of major cancer or currently on treating cancer
  • Major cardiovascular disease, respiratory disease, liver, hematologic diseases with complication
  • severe cognitive impairment / dementia / confusion state
  • past history within the last 12 months or current episode of severe constipation severe constipation
  • Regular use of laxatives or colon motility-altering drugs (i. e. more than 2 - 3 times per week) in the last 28 days prior to screening and/or laxative use within 72 hours prior to administration of the preparation)
  • women who are pregnant or lactating
  • known phenylketonuria, glucose-6-phosphate dehydrogenase deficiency
  • those who were allergic to any preparation components.
  • those who, in the opinion of the investigator, should not be included in the study for any reason

Sites / Locations

  • Seoul national university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CleanViewAL

SUPREP

Arm Description

1L polyethylene glycol+ascorbic acid split dose

Oral sulfate solutiom

Outcomes

Primary Outcome Measures

Boston Bowel Preparation Scale (BBPS)
Bowel cleansing score

Secondary Outcome Measures

questionnaire gathered for Tolerability, compliance, satisfaction
information gathered via questionnaire

Full Information

First Posted
February 15, 2021
Last Updated
July 4, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04758156
Brief Title
Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy
Official Title
Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy: Prospective, Randomized, Parallel, Multi-center Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparison between a 1L of polyethylene glycol+ascorbic acid as a split dose and oral sulfate solution bowel preparation for colonoscopy study design: prospective, randomized, parallel, multi-center trial in 3 hospitals in Korea ( Seoul National University hospital, Seoul National University Bundang hospital, Seoul Metropolitan Government-Seoul National University ) patient inclusion criteria - aged 20-75 adults (out-clinic patients) scheduled for colonoscopy for any indication within the normal process of care

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenoma, Colonic Polyp

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CleanViewAL
Arm Type
Experimental
Arm Description
1L polyethylene glycol+ascorbic acid split dose
Arm Title
SUPREP
Arm Type
Placebo Comparator
Arm Description
Oral sulfate solutiom
Intervention Type
Drug
Intervention Name(s)
CleanViewAL
Intervention Description
1L PEG + ascorbic acid bowel preparation for colonoscopy
Intervention Type
Drug
Intervention Name(s)
SUPREP
Intervention Description
Oral sulfate solution for colonoscopy bowel preparation
Primary Outcome Measure Information:
Title
Boston Bowel Preparation Scale (BBPS)
Description
Bowel cleansing score
Time Frame
at the time of colonoscopy procedure
Secondary Outcome Measure Information:
Title
questionnaire gathered for Tolerability, compliance, satisfaction
Description
information gathered via questionnaire
Time Frame
on the 1 day of colonoscopy via questionnaire

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult out clinic patients scheduled for colonoscopy for any indication within the normal process of care Exclusion Criteria: previous history of significant gastrointestinal surgeries (except for appendectomy) known or clinically suspicious Inflammatory bowel disease patients known or suspected ileus/ GI obstruction previous history of major cancer or currently on treating cancer Major cardiovascular disease, respiratory disease, liver, hematologic diseases with complication severe cognitive impairment / dementia / confusion state past history within the last 12 months or current episode of severe constipation severe constipation Regular use of laxatives or colon motility-altering drugs (i. e. more than 2 - 3 times per week) in the last 28 days prior to screening and/or laxative use within 72 hours prior to administration of the preparation) women who are pregnant or lactating known phenylketonuria, glucose-6-phosphate dehydrogenase deficiency those who were allergic to any preparation components. those who, in the opinion of the investigator, should not be included in the study for any reason
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Jung Lee, MD, PhD
Phone
+82-2-740-3439
Email
guswjd80@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Pil Im, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul national university hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Jung Lee, MD, PhD
Phone
+82-2-740-3439
Email
guswjd80@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy

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