A Phase 3 Trial in Bowel Preparation for Colonoscopy

Phase 3

Completed

• Conditions: Bowel Preparation
• Interventions: Drug: CTP0301-B; Drug: CTP0301-A; Drug: Cool prep

• Registration Number: NCT05870553
• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-30
• Study First Submitted: 2023-04-21
• Primary Completion: 2023-05-12
• Study Completion: 2023-05-12
• Study First Submitted QC: 2023-05-21
• Study First Posted: 2023-05-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTP0301-B	CTP0301-B	Subjects who are randomized into this group will take CTP0301-B before the morning of colonoscopy.
CTP0301-A	CTP0301-A	Subjects who are randomized into this group will take CTP0301-A from the evening before colonoscopy to the morning of colonoscopy.
Cool prep	Cool prep	Subjects who are randomized into this group will take Cool prep from the evening before colonoscopy to the morning of colonoscopy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Taejoon Pharmaceutical Co., Ltd.; 🇰🇷 Seoul, Korea, Republic of