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Completed

NCT Number: NCT05670470

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

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

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong, 05278, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTP0303

Drug

Subjects who are randomized into group CTP0303 will receive bowel preparation from evening to next morning.

Orafang Tab

Drug

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

Primary outcomes

  1. Number of Patients With Successful Bowel Cleansing (Overall Colon)

    Time frame: 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 outcomes

  1. Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)

    Time frame: 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.

  2. Adenoma/Polyp Detection Rate (Overall Colon)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taejoon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: PROPELLER

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 4, 2023
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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