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

Study Overview
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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

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

Conditions
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Colon Adenoma, Colonic Polyp

Intervention / Treatment
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* Drug: CleanViewAL
* Drug: SUPREP


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CleanViewAL<br>1L polyethylene glycol+ascorbic acid split dose | Drug: CleanViewAL<br>* 1L PEG + ascorbic acid bowel preparation for colonoscopy<br>|
| Placebo Comparator: SUPREP<br>Oral sulfate solutiom | Drug: SUPREP<br>* Oral sulfate solution for colonoscopy bowel preparation<br>|

What is the study measuring?
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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 |