A Phase 3 interventional study of GNS-212-E1 and GNS-212-E2 in Colonoscopy and Bowel Preparation, sponsored by Gunkang Pharmaceuticals, Inc. Completed at 1 site in South Korea. Open to participants aged 19 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Gunkang Pharmaceuticals, Inc · Phase 3, Interventional, and Treatment
This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial.
This is the only study on the registry with Gunkang Pharmaceuticals, Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
For women of childbearing potential, those who agree to use a medically acceptable contraceptive method* during the clinical trial period
*hormonal contraceptive, implantation of intrauterine device or intrauterine system, Infertility procedures/surgery (e.g., bilateral ovarian ligation, vasectomy)
Exclusion Criteria:
Drug: GNS-212-E1
Drug: GNS-212-E2
Drug: GNS-212-ER
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.
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 study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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