Bowel Preparation
Conditions
Keywords
bowel preparation
Brief summary
A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy
Detailed description
This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.
Interventions
DRUGCTP0302-A
Subjects randomized into group CTP0302-A will take a bowel preparation from the evening until the following morning.
DRUGCTP0302-B
Subjects randomized into group CTP0302-B will take a bowel preparation on the Colonoscopy day
DRUGConventional OST
Subjects randomized into group Conventional OST will take a bowel preparation from the evening until the following morning.
Sponsors
Taejoon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 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 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. * Pregnant women or pregnant women or pregnant women * 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. * People who have hypersensitivity or allergies to clinical trial drug components.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of subjects With successful Bowel Cleansing | 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 |
|---|---|---|
| Each segments ratio of subject with successful Bowel Cleansing | 1 day of scheduled colonoscopy | Evaluate the HCS grade evaluation, polyp or adenoma detection rate, etc. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Acute gastropathy probability score | 1 day of scheduled colonoscopy | According to 'The Manual of Gastric Mucosal Assessment', it's graded on a scale of 'Possible' to 'Very likely'. |
Countries
South Korea
Outcome results
None listed