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

Bowel Preparation Clinical Trial

— PROPELLER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05670470
• Other study ID #: CTP0303
• Status: Completed
• Phase: Phase 3
• Start date: September 21, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: January 2023
• Source: Taejoon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 31, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Drug:
• CTP0303
Subjects who are randomized into group CTP0303 will receive bowel preparation from evening to next morning.
• Orafang Tab
Subjects who are randomized into group Orafang Tab will receive bowel preparation from evening to next morning.

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul	Gangdong

Sponsors (1)

Lead Sponsor	Collaborator
Taejoon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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