Bowel Preparation
Conditions
Keywords
bowel preparation
Brief summary
This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.
Interventions
DRUGTJP-008-1
Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day.
DRUGTJP-008-2
Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning.
DRUGCoolprep powder
Subjects who are randomized into group Coolprep will receive bowel preparation from evening to next morning.
Sponsors
Taejoon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients must provide written informed consent. * Male and female outpatients and inpatients aged: ≥19 * Patients BMI shoule be ≤ 30
Exclusion criteria
* Patients with past history within last 12 months or current episode of severe constipation * Known glucose-6-phosphate dehydrogenase (G6PD) deficiency. * Known phenylketonuria. * Clinically relevant findings on physical examination based on the Investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of subjects With successful Bowel Cleansing | 1 day of scheduled colonoscopy |
Secondary
| Measure | Time frame |
|---|---|
| Easch segments ratio of subject with successful Bowel Cleansing | 1 day of scheduled colonoscopy |
Countries
South Korea
Outcome results
None listed