A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy

Phase 3

Completed

• Conditions: Bowel Preparation
• Interventions: Drug: CTP0302-B; Drug: CTP0302-A; Drug: Conventional OST

• Registration Number: NCT06287606
• Lead Sponsor: Taejoon Pharmaceutical Co., Ltd.

Brief Summary

A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy

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: 2023-08-29
• Primary Completion: 2024-01-04
• Study Completion: 2024-01-04
• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-03-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• Patients must provide written informed consent.
• Male and female outpatients and inpatients aged: ≥19
• Patients BMI shoule be ≤ 30

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
CTP0302-B	CTP0302-B	One day dose
CTP0302-A	CTP0302-A	2 days split-dose
Conventional OST	Conventional OST	2 days split-dose

Primary Outcome Measures

Name	Time	Method
Ratio of subjects With successful Bowel Cleansing	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
Each segments ratio of subject with successful Bowel Cleansing	1 day of scheduled colonoscopy	Evaluate the HCS grade evaluation, polyp or adenoma detection rate, etc.

Trial Locations

Locations (1)

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