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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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ClinicalTrials.gov Identifier: NCT04758156
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Hyun Jung Lee, Seoul National University Hospital

Study Description
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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


Condition or disease Intervention/treatment Phase
Colon Adenoma Colonic Polyp Drug: CleanViewAL Drug: SUPREP Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CleanViewAL
1L polyethylene glycol+ascorbic acid split dose
 Drug: CleanViewAL
1L PEG + ascorbic acid bowel preparation for colonoscopy
Placebo Comparator: SUPREP
Oral sulfate solutiom
 Drug: SUPREP
Oral sulfate solution for colonoscopy bowel preparation


Outcome Measures
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Primary Outcome Measures :
  1. Boston Bowel Preparation Scale (BBPS) [ Time Frame: at the time of colonoscopy procedure ]
    Bowel cleansing score


Secondary Outcome Measures :
  1. questionnaire gathered for Tolerability, compliance, satisfaction [ Time Frame: on the 1 day of colonoscopy via questionnaire ]
    information gathered via questionnaire


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758156


Contacts
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Contact: Hyun Jung Lee, MD, PhD +82-2-740-3439 guswjd80@gmail.com

Locations
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Korea, Republic of
Seoul national university hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Hyun Jung Lee, MD, PhD    +82-2-740-3439    guswjd80@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jong Pil Im, MD, PhD Seoul National University Hospital
More Information
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Responsible Party: Hyun Jung Lee, Assistant Professor, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04758156    
Other Study ID Numbers: 1905-1831
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical