A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial

Study Overview
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Brief Summary
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This is a prospective randomized study compared with active control arm.

Detailed Description
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This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.

Official Title
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A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy

Conditions
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Bowel Preparation

Intervention / Treatment
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* Drug: CTP0303
* Drug: Orafang Tab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTP0303<br> | Drug: CTP0303<br>* Subjects who are randomized into group CTP0303 will receive bowel preparation from evening to next morning.<br>|
| Active Comparator: Orafang Tab<br> | Drug: Orafang Tab<br>* Subjects who are randomized into group Orafang Tab will receive bowel preparation from evening to next morning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Successful Bowel Cleansing (Overall Colon) | 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. | 1 day of scheduled colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma/Polyp Detection Rate (Overall Colon) | 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. | 1 day of scheduled colonoscopy | 
| Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens) | 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. | 1 day of scheduled colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel Preparation