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

NCT04758156 | Unknown Phase 4

• 1 other identifier: 1905-1831
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Colon Adenoma; Colonic Polyp

Outcome Measures

Primary Outcomes (1)

• Boston Bowel Preparation Scale (BBPS)

  Bowel cleansing score

  at the time of colonoscopy procedure

Secondary Outcomes (1)

• questionnaire gathered for Tolerability, compliance, satisfaction

  on the 1 day of colonoscopy via questionnaire

Study Arms (2)

CleanViewAL

EXPERIMENTAL

1L polyethylene glycol+ascorbic acid split dose

Drug: CleanViewAL

SUPREP

PLACEBO COMPARATOR

Oral sulfate solutiom

Drug: SUPREP

Interventions

CleanViewAL DRUG

1L PEG + ascorbic acid bowel preparation for colonoscopy

CleanViewAL

SUPREP DRUG

Oral sulfate solution for colonoscopy bowel preparation

SUPREP

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul national university hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jong Pil Im, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Jung Lee, MD, PhD

CONTACT

+82-2-740-3439; guswjd80@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, MD, PhD

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 17, 2021
• Study Start: August 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)