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

NCT ID: NCT04758156

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Colon Adenoma Colonic Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CleanViewAL

1L polyethylene glycol+ascorbic acid split dose

Group Type EXPERIMENTAL

CleanViewAL

Intervention Type DRUG

1L PEG + ascorbic acid bowel preparation for colonoscopy

SUPREP

Oral sulfate solutiom

Group Type PLACEBO_COMPARATOR

SUPREP

Intervention Type DRUG

Oral sulfate solution for colonoscopy bowel preparation

Interventions

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CleanViewAL

1L PEG + ascorbic acid bowel preparation for colonoscopy

Intervention Type DRUG

SUPREP

Oral sulfate solution for colonoscopy bowel preparation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyun Jung Lee

Assistant Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Pil Im, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul national university hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyun Jung Lee, MD, PhD

Role: CONTACT

+82-2-740-3439

Facility Contacts

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Hyun Jung Lee, MD, PhD

Role: primary

+82-2-740-3439

Other Identifiers

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1905-1831

Identifier Type: -

Identifier Source: org_study_id

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