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

Sponsor

Taejoon Pharmaceutical Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05670470

Collaborator

(none)

Enrollment

Location

Arms

3.4

Anticipated Duration (Months)

25.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bowel Preparation	Drug: CTP0303 Drug: Orafang Tab	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 21, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyung Hee University Hospital at Gangdong	Seoul	Gangdong	Korea, Republic of	05278

Sponsors and Collaborators

Taejoon Pharmaceutical Co., Ltd.

Investigators

Principal Investigator: Jae Myung Cha, MD, PhD, Kyung Hee University Hospital at Gangdong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taejoon Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05670470

Other Study ID Numbers:

CTP0303

First Posted:

Jan 4, 2023

Last Update Posted:

Jan 4, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Taejoon Pharmaceutical Co., Ltd.

Bowel Preparation

Study Results

No Results Posted as of Jan 4, 2023