A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 137
- Locations
- 1
- Primary Endpoint
- Number of Patients With Successful Bowel Cleansing (Overall Colon)
Study Overview
Brief Summary
This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
- •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.
Arms & Interventions
CTP0301-A
Subjects who are randomized into this group will take CTP0301-A from the evening before colonoscopy to the morning of colonoscopy.
Intervention: CTP0301-A (Drug)
CTP0301-B
Subjects who are randomized into this group will take CTP0301-B before the morning of colonoscopy.
Intervention: CTP0301-B (Drug)
Cool prep
Subjects who are randomized into this group will take Cool prep from the evening before colonoscopy to the morning of colonoscopy.
Intervention: Cool prep (Drug)
Outcomes
Primary Outcomes
Number of Patients With Successful Bowel Cleansing (Overall Colon)
Time Frame: 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 Outcomes
- Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)(1 day of scheduled colonoscopy)