A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Bowel Preparation
• Intervention / Treatment: Drug: CTP0302-A; Drug: CTP0302-B; Drug: Conventional OST

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Taejoon Pharmaceutical Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CTP0302-A; 2 days split-dose	Drug: CTP0302-A; Subjects randomized into group CTP0302-A will take a bowel preparation from the evening until the following morning.; Other Names: Treatment Group A
Experimental: CTP0302-B; One day dose	Drug: CTP0302-B; Subjects randomized into group CTP0302-B will take a bowel preparation on the Colonoscopy day; Other Names: Treatment Group B
Active Comparator: Conventional OST; 2 days split-dose	Drug: Conventional OST; Subjects randomized into group Conventional OST will take a bowel preparation from the evening until the following morning.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Acute gastropathy probability score	According to 'The Manual of Gastric Mucosal Assessment', it's graded on a scale of 'Possible' to 'Very likely'.	1 day of scheduled colonoscopy

Collaborators and Investigators

• Sponsor: Taejoon Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Jaemyung Cha, MD. PhD, Kyung Hee University Hospital at Gangdong

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2023
• Primary Completion (Actual): January 17, 2024
• Study Completion (Estimated): May 14, 2024

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: bowel preparation
• Other Study ID Numbers: CTP0302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No