This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
318
Subjects who are randomized into this group will take GNS-212-E1 from the evening before colonoscopy to the morning of colonoscopy.
Subjects who are randomized into this group will take GNS-212-E2 from the evening before colonoscopy to the morning of colonoscopy.
Subjects who are randomized into this group will take active control drug (PEG3350) from the evening before colonoscopy to the morning of colonoscopy.
Seoul National University Hospital
Seoul, South Korea
To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale)
HCS grading of A and B would be classified as successful while C and D would be classified as not successful
Time frame: on the day of scheduled colonoscopy
Overall rate of bowel preparation
Percentage of test subjects for respective HCS grades
Time frame: On the day of colonoscopy
Overall patient satisfaction and compliance
Subject questionnaire evaluation total volume, taste etc.
Time frame: before and on the day of colonoscopy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.