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

Colonic Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758156
• Other study ID #: 1905-1831
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Seoul National University Hospital
• Contact: Hyun Jung Lee, MD, PhD
• Phone: +82-2-740-3439
• Email: guswjd80[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colonic Polyp
• Colonic Polyps

Intervention

Drug:
• CleanViewAL
1L PEG + ascorbic acid bowel preparation for colonoscopy
• SUPREP
Oral sulfate solution for colonoscopy bowel preparation

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Scale (BBPS)	Bowel cleansing score	at the time of colonoscopy procedure
Secondary	questionnaire gathered for Tolerability, compliance, satisfaction	information gathered via questionnaire	on the 1 day of colonoscopy via questionnaire