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| ID | Type | Description | Link |
|---|---|---|---|
| 101772 | Other Identifier | MFDS |
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This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GNS-212-E1 | Experimental |
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| GNS-212-E2 | Experimental |
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| GNS-212-ER | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GNS-212-E1 | Drug | Subjects who are randomized into this group will take GNS-212-E1 from the evening before colonoscopy to the morning of colonoscopy. |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale) | HCS grading of A and B would be classified as successful while C and D would be classified as not successful | on the day of scheduled colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall rate of bowel preparation | Percentage of test subjects for respective HCS grades | On the day of colonoscopy |
| Overall patient satisfaction and compliance | Subject questionnaire evaluation total volume, taste etc. |
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Inclusion Criteria:
Adult men and women between 19 years and 79 age or older as of the date of consent in writing
19 kg/㎡ ≤ BMI < 30 kg/㎡
a prospective colonoscopy patient
For women of childbearing potential, those who agree to use a medically acceptable contraceptive method* during the clinical trial period
*hormonal contraceptive, implantation of intrauterine device or intrauterine system, Infertility procedures/surgery (e.g., bilateral ovarian ligation, vasectomy)
A person who voluntarily agrees to participate in this clinical trial and signs a written agreement Abbreviation
Women of childbearing potential must have a negative serum or urine pregnancy test before Investigational Product administration
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byeong Gwan Kim | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| GNS-212-E2 | Drug | Subjects who are randomized into this group will take GNS-212-E2 from the evening before colonoscopy to the morning of colonoscopy. |
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| GNS-212-ER | Drug | Subjects who are randomized into this group will take active control drug (PEG3350) from the evening before colonoscopy to the morning of colonoscopy. |
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| before and on the day of colonoscopy |