Colonic Diseases, Digestive System Disease, Gastrointestinal Disease, Intestinal Disease
Conditions
Brief summary
This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.
Interventions
DRUGPBK_M2101 2-Day
Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.
DRUGPBK_M2101 1-Day
Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
DRUGOral Sulfate Tablet 2-Day
Subjects who are randomized into group active comparative will receive bowel preparation from evening to next morning.
Sponsors
Pharmbio Korea Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients who is informed and give a consent in voluntary * Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy * BMI 19≤and\<30
Exclusion criteria
* Patients who participate in other interventional study or had participated within 30 days before screening * Pregnant or breast-feeding women who do not want to stop breast-feeding * Uncontrolled hypertension * Uncontrolled diabetes * Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance * HIV infection and/or chronic hepatitis B or C * Patients who has a difficulty to participate because of severe nausea or vomiting * History of colon surgery and abdominal surgery within 6 month; need an emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful cleansing rate | From day of first dosing to day of colonoscopy | %Patient with HCS-graded A or B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean segmental cleansing score | From day of first dosing to day of colonoscopy | 5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum. |
| Mean cecal intubation time | From day of first dosing to day of colonoscopy | — |
| Mean colonoscopy withdrawal time | From day of first dosing to day of colonoscopy | — |
| Overall cleansing rate | From day of first dosing to day of colonoscopy | %Patient with each HCS-grade (A, B, C, D) |
| Patient satisfaction | From day of first dosing to day of colonoscopy | Subject questionnaire (Taste, Difficulty, Ease of taking) |
| Polyp detection rate | From day of first dosing to day of colonoscopy | — |
| Treatment compliance | From day of first dosing to day of colonoscopy | Dosage taken/Dosage scheduled |
Countries
South Korea
Contacts
Primary ContactManager Clinical Trial team, Pharmbio Korea
Outcome results
None listed