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

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

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

Study Overview

• Status: Completed
• Conditions: Bowel Preparation
• Intervention / Treatment: Drug: CTP0303; Drug: Orafang Tab

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): 84
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sukyoung Kwon, MPH., PhD; Phone Number: +82-799-0175; Email: skkwon@taejoon.co.kr

Study Locations

• Korea, Republic of
  • Gangdong
    • Seoul, Gangdong, Korea, Republic of, 05278
      • Kyung Hee University Hospital at Gangdong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CTP0303	Drug: CTP0303; Subjects who are randomized into group CTP0303 will receive bowel preparation from evening to next morning.
Active Comparator: Orafang Tab	Drug: Orafang Tab; Subjects who are randomized into group Orafang Tab will receive bowel preparation from evening to next morning.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: January 2, 2023
• First Submitted That Met QC Criteria: January 2, 2023
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Bowel Preparation
• Other Study ID Numbers: CTP0303

Drug and device information, study documents

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