Kyung Hee University Hospital at Gangdong
Seoul, Gangdong, 05278, South Korea
NCT Number: NCT05670470
This is a prospective randomized study compared with active control arm.
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Notify Me19 year and older
All sexes
Interventional
Phase 3
Seoul, Gangdong, 05278, South Korea
This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects who are randomized into group CTP0303 will receive bowel preparation from evening to next morning.
Subjects who are randomized into group Orafang Tab will receive bowel preparation from evening to next morning.
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.
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.
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.
Taejoon Pharmaceutical Co., Ltd.
Industry
A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy
Acronym: PROPELLER
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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