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

Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy: Prospective, Randomized, Parallel, Multi-center Trial

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

Study Overview

• Status: Recruiting
• Conditions: Colonic Polyp; Colon Adenoma
• Intervention / Treatment: Drug: CleanViewAL; Drug: SUPREP

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hyun Jung Lee, MD, PhD; Phone Number: +82-2-740-3439; Email: guswjd80@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hyun Jung Lee, MD, PhD; Phone Number: +82-2-740-3439; Email: guswjd80@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Bowel Preparation Scale (BBPS)	Bowel cleansing score	at the time of colonoscopy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
questionnaire gathered for Tolerability, compliance, satisfaction	information gathered via questionnaire	on the 1 day of colonoscopy via questionnaire

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jong Pil Im, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ANTICIPATED): July 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (ACTUAL): February 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps
• Other Study ID Numbers: 1905-1831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No