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This study evaluates the efficacy, safety and tolerability of PBK-1701TC for bowel cleansing before colonoscopy. Half the participants will receive PBK-1701TC and while the other will receive standard oral preparation.
This study is a prospective, randomized, single-blinded, parallel, 2-treatment, multi-center clinical trial. A total of 224 subjects will participate to this study and be assigned to the test group or the control group. The subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. Subject will take the second dose early in the morning of the colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBK-1701TC | Experimental | 2-Day Split-Dosing Regimen |
|
| Standard oral preparation | Active Comparator | 2-Day Split-Dosing Regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBK-1701TC | Drug | The subject will receive PBK-1701TC for colonoscopy. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Successful cleansing rate | %Patient with HCS-graded A or B | Two days (from day of first dosing to day of colonoscopy) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall cleansing rate | %Patient with each HCS-grade (A, B, C, D) | Two days (from day of first dosing to day of colonoscopy) |
| Mean segmental cleansing score | Mean HCS-grade in each segment (5 Segments: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Gwangju | South Korea | ||||
| Kangbuk Samsung Hospital |
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| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000710250 | pbk-1701TC |
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| Standard oral preparation |
| Drug |
The subject will receive the standard oral preparation for colonoscopy |
|
| Two days (from day of first dosing to day of colonoscopy) |
| Mean cecal intubation time | Two days (from day of first dosing to day of colonoscopy) |
| Mean colonoscopy withdrawal time | Two days (from day of first dosing to day of colonoscopy) |
| Treatment compliance | %Patient who have completed taking the investigational products | Two days (from day of first dosing to day of colonoscopy) |
| Patient satisfaction | Patient questionnaire about any patient discomfort related to investigational products | Two days (from day of first dosing to day of colonoscopy) |
| Polyp detection rate | Two days (from day of first dosing to day of colonoscopy) |
| Seoul |
| South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Kyunghee University Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |