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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Colonic Polyp; Colon Adenoma

Treatments: Drug: CleanViewAL; Drug: SUPREP

Study type: Interventional

Funder types: Other

Identifiers

NCT04758156

1905-1831

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

CleanViewAL

Experimental group

Description:

1L polyethylene glycol+ascorbic acid split dose

Treatment:

Drug: CleanViewAL

SUPREP

Placebo Comparator group

Description:

Oral sulfate solutiom

Treatment:

Drug: SUPREP