Taejoon Pharmaceutical Co., Ltd.
Seoul, South Korea
NCT Number: NCT06287606
A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy
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Notify Me19 year and older
All sexes
Interventional
Phase 3
Seoul, 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 randomized into group CTP0302-A will take a bowel preparation from the evening until the following morning.
Other names: Treatment Group A
Subjects randomized into group CTP0302-B will take a bowel preparation on the Colonoscopy day
Other names: Treatment Group B
Subjects randomized into group Conventional OST will take a bowel preparation from the evening until the following morning.
Other names: Control group
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
Evaluate the HCS grade evaluation, polyp or adenoma detection rate, etc.
Time frame: 1 day of scheduled colonoscopy
According to 'The Manual of Gastric Mucosal Assessment', it's graded on a scale of 'Possible' to 'Very likely'.
Taejoon Pharmaceutical Co., Ltd.
Industry
A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy
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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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