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_M2502 1-Day
Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
DRUGPBK_M2502 2-Day
Subjects who are randomized into group test 1 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 | Day 1 (day of colonoscopy) | %Patient with HCS-graded A or B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean segmental cleansing score | Day 1 (day of colonoscopy) | 5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum. |
| Mean cecal intubation time | Day 1 (day of colonoscopy) | — |
| Mean colonoscopy withdrawal time | Day 1 (day of colonoscopy) | — |
| Overall cleansing rate | Day 1 (day of colonoscopy) | %Patient with each HCS-grade (A, B, C, D) |
| Patient satisfaction | Day 1 (day of colonoscopy) | Subject questionnaire (Taste, Difficulty, Ease of taking) |
| Polyp detection rate | Day 1 (day of colonoscopy) | — |
| Treatment compliance | Day 1 (day of colonoscopy) | Dosage taken/Dosage scheduled |
Countries
South Korea
Contacts
Primary ContactManager Clinical Trial team, Pharmbio Korea
Outcome results
None listed