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| Name | Class |
|---|---|
| Symyoo | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 | Experimental | CDFR0612 Solution 150mL will be mixed with water of 350ml to prepare a bowel cleansing preparation solution 500mL. Take it within 30min. After then, take additional water 500ml within 30min. These processes will be in evening at one day before colonoscopy and in early morning at the same day of colonoscopy. |
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| Test 2 | Experimental | CDFR0613 Solution 150mL will be mixed with water of 350ml to prepare a bowel cleansing preparation solution 500mL. Take it within 30min. After then, take additional water 500ml within 30min. These processes will be in evening at one day before colonoscopy and in early morning at the same day of colonoscopy. |
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| Comparator | Active Comparator | Coolprep Powder A and B will be mixed with water to prepare a mixture of a bowel cleansing preparation solution 500mL. Repeat it twice. Take these of IL (2 * 500mL) within 1 hour. After then, take additional 500ml water. These processes will be in evening at one day before colonoscopy and in early morning at the same day of colonoscopy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDFR0612 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful cleansing rate | %Patient with HCS-graded A or B | post-colonoscopy at Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall cleansing rate | %Patient with each HCS-grade (A, B, C, D) | post-colonoscopy at Day 2 |
| Mean segmental cleansing score | 5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events | For 4 weeks after treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Woo KIM, M.D. | Seoul St. Mary's Hospital | Principal Investigator |
| Dongjin Yoo, M.D. | Symyoo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uijengbu St.Mary's Hospital | Uijengbu-si | Gyeonggi-do | 480-717 | South Korea | ||
| Seoul St.Mary's Hospital |
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| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C520497 | MoviPrep |
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| CDFR0613 | Drug | 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. |
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| Coolprep Powder | Drug | 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. |
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| post-colonoscopy at Day 2 |
| Patient reported outcomes | Patient questionnaire about any patient discomfort related to study drug administration | Post-dosing at Day 1 and Day 2 |
| Cecal intubation rate | post-colonoscopy at Day 2 |
| Mean cecal intubation time | post-colonoscopy at Day 2 |
| Mean colonoscopy withdrawal time | post-colonoscopy at Day 2 |
| Treatment Compliance | Post dosing at Day 2 |
| Polyp detection rate | post-colonoscopy at Day 2 |
| Seoul |
| Seocho-gu, Banpo-daero |
| 222 |
| South Korea |
| Korea University Anam Hospital | Seongbuk-gu | Seoul | 136-705 | South Korea |
| Korea University Ansan Hospital | Ansan | 15355 | South Korea |