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This study compares the effectiveness and stability of intestinal tablet (OST), an oral sulfate table (OST), developed in the form of pills, with 2L-PEG/Asc for examinees aged 70 or older who are scheduled for colonoscopy.
This study is comparison for efficacy and safety of bowel preparation between oral sulfate table and 2L-polyethylene glycol/ascorbate in elderly: multicenter, prospective, investigator single-blinded, randomized study. A total of 256 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 |
|---|---|---|---|
| OST | Experimental | 2 days split dosing regimen |
|
| 2L-PEG/Asc | Active Comparator | 2 days split dosing regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OST | Drug | The subject will receive Orafang for colonoscopy |
| |
| 2L-PEG/Asc |
| Measure | Description | Time Frame |
|---|---|---|
| Successful cleaning rate1 | %Patient with Boston Bowel Preparation Scale (BBPS) scored over 2 in all segment | Two days (from day of first dosing to day of colonoscopy) |
| Successful cleaning rate2 | %Patient with HCS-graded A or B | Two days (from day of first dosing to day of colonoscopy) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment compliance | %Patient who have completed taking the investigational products | Two days (from day of first dosing to day of colonoscopy) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction assessed by questionnaire | maximum score 10, minimum score0 , higher scores mean a better satisfaction | Two days (from day of first dosing to day of colonoscopy) |
| Adenoma/Polyp detection rate, ADR /PDR |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cha Jaemyeong, M.D, Ph.D | Contact | +82-2-440-6113 | clicknox@hanmail.net | |
| Yoon Jinyeong | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Cha Jaemyeong, M.D, Ph.D | Kyung Hee University Hospital at Gangdong | Study Chair |
| Gang Hoseok, M.D, Ph.D | HALLYM UNIV. MEDICAL CENTER | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38492010 | Derived | Kang HS, Na SY, Yoon JY, Jung Y, Seo GS, Cha JM. Efficacy, tolerability, and safety of oral sulfate tablet versus 2 L-polyethylene glycol/ascorbate for bowel preparation in older patients: prospective, multicenter, investigator single-blinded, randomized study. J Gastroenterol. 2024 May;59(5):402-410. doi: 10.1007/s00535-024-02089-9. Epub 2024 Mar 16. |
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| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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multicenter, prospective, investigator single-blinded, randomized study
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| Drug |
The subject will receive 2L-PEG/Asc for colonoscopy |
|
Adenoma/Polyp detection rate over 25%
| Two days (from day of first dosing to day of colonoscopy) |
| clean cecal intubation time, colonoscopy time | clean cecal intubation time, colonoscopy time | Two days (from day of first dosing to day of colonoscopy) |
| Seo Geomseok, M.D, Ph.D |
| Wonkwang University Hospital |
| Principal Investigator |
| Jeong Yunho, M.D, Ph.D | Soon Chun Hanyang University College of Medicine | Principal Investigator |
| Na Suyeong, M.D, Ph.D | Incheon St.Mary's Hospital | Principal Investigator |