Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy (NCT06317350) | Clinical Trial Compass
CompletedPhase 3
Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy
South Korea318 participantsStarted 2024-03-11
Plain-language summary
This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial.
Who can participate
Age range
19 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult men and women between 19 years and 79 age or older as of the date of consent in writing
. 19 kg/㎡ ≤ BMI \< 30 kg/㎡
. a prospective colonoscopy patient
. For women of childbearing potential, those who agree to use a medically acceptable contraceptive method\* during the clinical trial period
. A person who voluntarily agrees to participate in this clinical trial and signs a written agreement Abbreviation
. Women of childbearing potential must have a negative serum or urine pregnancy test before Investigational Product administration
Exclusion criteria
. A person having constipation who is regularly administered laxatives or gastrointestinal motility promoters
. A person with a history of significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection
. A person diagnosed with acute coronary disease, arrhythmia, cardiomyopathy, cardiac valvular disease, aortic and peripheral vascular disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale)
. Uncontrolled chronic medical illnesses or suspected symptoms that hinder participation such as major cardiac, renal, and metabolic (ex, Subjects with severe renal disease).
. Clinically significant abnormal laboratory values of screening.(Creatinine, AST or ALT )
. Active hepatitis B or hepatitis C with positive HBsAg and HCV Ab tests at screening
. Positive for Human Immuno-deficiency Virus (HIV) at the time of screening