Colonic Disease, Intestinal Disease
Conditions
Keywords
colonoscopy, orafang, bowel cleaning
Brief summary
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.
Detailed description
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.
Interventions
DRUGOST
The subject will receive Orafang for colonoscopy
DRUG2L-PEG/Asc
The subject will receive 2L-PEG/Asc for colonoscopy
Sponsors
Pharmbio Korea Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Intervention model description
multicenter, prospective, investigator single-blinded, randomized study
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age over 70 * Patients who is scheduled a colonoscopy * Patients who is informed and give a consent in voluntary
Exclusion criteria
* History of colectomy * Patients over American Society of Anesthesiology class III * Patients who has difficulty swallowing * In the case of abnormal findings requiring treatment in the basic blood test * Patients with uncontrollable chronic diseases * Patients suspected of having Paralytic ileus or intestinal obstruction. * Patients who complains of alarm sign (severe abdominal pain, weight loss, anemia, gastrointestinal bleeding, etc.) * Patients who has a history of drug abuse and addiction * Patients who for any reason, are deemed by the Investigator to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful cleaning rate1 | Two days (from day of first dosing to day of colonoscopy) | %Patient with Boston Bowel Preparation Scale (BBPS) scored over 2 in all segment |
| Successful cleaning rate2 | Two days (from day of first dosing to day of colonoscopy) | %Patient with HCS-graded A or B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment compliance | Two days (from day of first dosing to day of colonoscopy) | %Patient who have completed taking the investigational products |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction assessed by questionnaire | Two days (from day of first dosing to day of colonoscopy) | maximum score 10, minimum score0 , higher scores mean a better satisfaction |
| Adenoma/Polyp detection rate, ADR /PDR | Two days (from day of first dosing to day of colonoscopy) | Adenoma/Polyp detection rate over 25% |
| clean cecal intubation time, colonoscopy time | Two days (from day of first dosing to day of colonoscopy) | clean cecal intubation time, colonoscopy time |
Contacts
Primary ContactCha Jaemyeong, M.D, Ph.D
Backup ContactYoon Jinyeong
Outcome results
None listed