The purpose of this study is to evaluate the safety and efficacy of CDFR0612 and CDFR0613 compared to PEG+picosulfate (Coolprep Powder) preparation. The effectiveness for bowel cleansing will be assessed with Harefield Cleansing Scale (HCS) by blinded assessor.
This study is a prospective, randomized, single-blinded, parallel, 3-treatment, multi-center clinical trial. A total of 297 subjects scheduled for colonoscopy will participate to this study and be assigned to 3 groups - CDFR0612, CDFR0613, or a comparator (Coolprep Powder). A subject will admit to hospital one day before colonoscopy and be administrated with study drug. In early morning at the that day of colonoscopy, he/she will be administrated with study drug again. Any subject will be carefully monitored for safety during hospitalisation (1 night) and additional 4 weeks follow-up period because this study is the first human trial of CDFR0612 and CDFR0613.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
310
Preparation 500mL is a mixture of CDFR0612 150mL and water 350mL. A total of 2L (Preparation 1L and additional water 1L) will be administrated divided into two in evening before and in early morning at that day of colonoscopy.
Preparation 500mL is a mixture of CDFR0613 150mL and water 350mL. A total of 2L (Preparation 1L and additional water 1L) will be administrated divided into two in evening before and in early morning at that day of colonoscopy.
Preparation 500mL is a water solution of Coolprep Powder A and B. A total of 3L (Preparation 2L and additional water 1L) will be administrated divided into two in evening before and in early morning at that day of colonoscopy.
Uijengbu St.Mary's Hospital
Uijengbu-si, Gyeonggi-do, South Korea
Seoul St.Mary's Hospital
Seoul, Seocho-gu, Banpo-daero, South Korea
Korea University Anam Hospital
Seongbuk-gu, Seoul, South Korea
Korea University Ansan Hospital
Ansan, South Korea
Successful cleansing rate
%Patient with HCS-graded A or B
Time frame: post-colonoscopy at Day 2
Overall cleansing rate
%Patient with each HCS-grade (A, B, C, D)
Time frame: post-colonoscopy at Day 2
Mean segmental cleansing score
5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.
Time frame: post-colonoscopy at Day 2
Patient reported outcomes
Patient questionnaire about any patient discomfort related to study drug administration
Time frame: Post-dosing at Day 1 and Day 2
Cecal intubation rate
Time frame: post-colonoscopy at Day 2
Mean cecal intubation time
Time frame: post-colonoscopy at Day 2
Mean colonoscopy withdrawal time
Time frame: post-colonoscopy at Day 2
Treatment Compliance
Time frame: Post dosing at Day 2
Polyp detection rate
Time frame: post-colonoscopy at Day 2
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