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This is a prospective randomized study compared with active control arm.
This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTP0303 | Experimental |
| |
| Orafang Tab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP0303 | Drug | Subjects who are randomized into group CTP0303 will receive bowel preparation from evening to next morning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Successful Bowel Cleansing (Overall Colon) | The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. | 1 day of scheduled colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens) | The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Myung Cha, MD, PhD | Kyung Hee University Hospital at Gangdong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital at Gangdong | Seoul | Gangdong | 05278 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37542674 | Derived | Jeon SR, Park SK, Yang DH, Cha JM. Comparison of a novel mini-oral sulfate tablet and the conventional oral sulfate tablet in bowel preparation for colonoscopy: a prospective, randomized, investigator-blinded, multicenter, non-inferior, phase 3 trial. J Gastroenterol. 2023 Nov;58(11):1114-1123. doi: 10.1007/s00535-023-02023-5. Epub 2023 Aug 5. |
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| Orafang Tab | Drug | Subjects who are randomized into group Orafang Tab will receive bowel preparation from evening to next morning. |
|
| 1 day of scheduled colonoscopy |
| Adenoma/Polyp Detection Rate (Overall Colon) | Through colonoscopy, a blinded central reader checks whether polyp or adenoma is found, and if more than one polyp or adenoma is found in a patient, it is defined as "detection." The polyp detection rate (PDR) and adenoma detection rate (ADR) of the entire colon and ascending colon are defined as follows. | 1 day of scheduled colonoscopy |