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A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy
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 |
|---|---|---|---|
| CTP0302-A | Experimental | 2 days split-dose |
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| CTP0302-B | Experimental | One day dose |
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| Conventional OST | Active Comparator | 2 days split-dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP0302-A | Drug | Subjects randomized into group CTP0302-A will take a bowel preparation from the evening until the following morning. |
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| Measure | Description | Time Frame |
|---|---|---|
| Ratio of subjects With successful Bowel Cleansing | 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 |
|---|---|---|
| Each segments ratio of subject with successful Bowel Cleansing | Evaluate the HCS grade evaluation, polyp or adenoma detection rate, etc. | 1 day of scheduled colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Acute gastropathy probability score | According to 'The Manual of Gastric Mucosal Assessment', it's graded on a scale of 'Possible' to 'Very likely'. | 1 day of scheduled colonoscopy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaemyung Cha, MD. PhD | Kyung Hee University Hospital at Gangdong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taejoon Pharmaceutical Co., Ltd. | Seoul | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41306094 | Derived | Park SK, Jeon SR, Yang DH, Chun J, Cha JM. Efficacy and Safety of Bowel Cleansing with Mini S-Oral Sulfate Tablet versus the Conventional Oral Sulfate Tablet: A Prospective, Randomized, Investigator-Blinded, Multicenter, Noninferior, Phase 3 Trial. Gut Liver. 2026 Mar 15;20(2):294-304. doi: 10.5009/gnl250291. Epub 2025 Nov 27. |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| CTP0302-B | Drug | Subjects randomized into group CTP0302-B will take a bowel preparation on the Colonoscopy day |
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| Conventional OST | Drug | Subjects randomized into group Conventional OST will take a bowel preparation from the evening until the following morning. |
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| D008722 | Methods |