Bowel Preparation
Conditions
Keywords
Bowel Preparation
Brief summary
This is a prospective randomized study compared with active control arm.
Detailed description
This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.
Interventions
DRUGCTP0303
Subjects who are randomized into group CTP0303 will receive bowel preparation from evening to next morning.
DRUGOrafang Tab
Subjects who are randomized into group Orafang Tab 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
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and female outpatients and inpatients aged: ≥19 * A prospective colonoscopy person * Written informed consent to participate in the trial
Exclusion criteria
* Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon. * Patients with ongoing severe acute Inflammatory Bowel Disease * Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy, Hartmann's procedure and defunctioning ileostomy or other similar surgeries involving structure and function of the small or large colon. * Pregnant women or pregnant women or pregnant women * Patients who have not been confirmed to have COVID-19 for a month * Severe heart disease (cardiac failure (NYHA class 3 and 4)) * Acute coronary artery disease within 24 weeks before screening (an unstable angina pectoris, acute myocardial infarction), clinically significant arrhythmia, hypertrophic obstruction Cardiomyopathy, valvular disease, aortic and peripheral vascular diseases * Patients with severe chronic renal impairment (glomerular filtration rate less than 30ml/min/1.73m2) * People who have hypersensitivity or allergies to clinical trial drug components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Successful Bowel Cleansing (Overall Colon) | 1 day of scheduled colonoscopy | The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens) | 1 day of scheduled colonoscopy | The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. |
| Adenoma/Polyp Detection Rate (Overall Colon) | 1 day of scheduled colonoscopy | Through colonoscopy, a blinded central reader checks whether polyp or adenoma is found, and if more than one polyp or adenoma is found in a patient, it is defined as detection. The polyp detection rate (PDR) and adenoma detection rate (ADR) of the entire colon and ascending colon are defined as follows. |
Countries
South Korea
Outcome results
None listed