A Phase 3 Trial in Bowel Preparation for Colonoscopy

Study Overview
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Brief Summary
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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, Single-blinded (Evaluator), 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: CTP0301-A
* Drug: CTP0301-B
* Drug: Cool prep


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. 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: CTP0301-A<br>Subjects who are randomized into this group will take CTP0301-A from the evening before colonoscopy to the morning of colonoscopy. | Drug: CTP0301-A<br>* Bowel Preparation<br>* Other names: PEG 3350;|
| Experimental: CTP0301-B<br>Subjects who are randomized into this group will take CTP0301-B before the morning of colonoscopy. | Drug: CTP0301-B<br>* Bowel Preparation<br>* Other names: PEG 3350;|
| Active Comparator: Cool prep<br>Subjects who are randomized into this group will take Cool prep from the evening before colonoscopy to the morning of colonoscopy. | Drug: Cool prep<br>* Bowel Preparation<br>* Other names: PEG 3350;|

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 |
| --- | --- | --- |
| 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 |