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

Phase 3

Completed

• Conditions: Bowel Preparation
• Interventions: Drug: Orafang Tab; Drug: CTP0303

• Registration Number: NCT05670470
• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.

Brief Summary

This is a prospective randomized study compared with active control arm.

Detailed Description

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

Study Timeline

• Study Start: 2022-09-21
• Status Verified: 2023-01
• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-01-02
• Study First Posted: 2023-01-04
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-31
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orafang Tab	Orafang Tab	-
CTP0303	CTP0303	-

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.
Adenoma/Polyp Detection Rate (Overall Colon)	1 day of scheduled colonoscopy	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.

Trial Locations

Locations (1)

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Gangdong, Korea, Republic of