Phase
Condition
Colon Cancer Screening
Treatment
GNS-212-E1
GNS-212-ER
GNS-212-E2
Clinical Study ID
Ages 19-79 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult men and women between 19 years and 79 age or older as of the date of consentin writing
19 kg/㎡ ≤ BMI < 30 kg/㎡
a prospective colonoscopy patient
For women of childbearing potential, those who agree to use a medically acceptablecontraceptive method* during the clinical trial period
*hormonal contraceptive, implantation of intrauterine device or intrauterine system,Infertility procedures/surgery (e.g., bilateral ovarian ligation, vasectomy)
A person who voluntarily agrees to participate in this clinical trial and signs awritten agreement Abbreviation
Women of childbearing potential must have a negative serum or urine pregnancy testbefore Investigational Product administration
Exclusion
Exclusion Criteria:
A person having constipation who is regularly administered laxatives orgastrointestinal motility promoters
A person with a history of significant gastrointestinal surgeries, including colonicresection, subtotal colectomy, abdominoperineal resection
A person diagnosed with acute coronary disease, arrhythmia, cardiomyopathy, cardiacvalvular disease, aortic and peripheral vascular disease
Active infection or high fever above 38°C
Uncontrolled chronic medical illnesses or suspected symptoms that hinderparticipation such as major cardiac, renal, and metabolic (ex, Subjects with severerenal disease).
Clinically significant abnormal laboratory values of screening.(Creatinine, AST orALT )
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
Severe nausea or vomiting
Severe abdominal distension or abdominal pain
A person prone to aspiration or reflux
A person who undergoes colonoscopy for the following therapeutic purpose (1) balloondilatation of the stenosis area (2) non-toxic giant colon or decompression of theS-phase colitis (sigmoid volvulus) (3) Removal of foreign substances (4) Vasculardysplasia, ulcer, tumor and treatment of bleeding after polypectomy
A person who is hypersensitive to the ingredients of a clinical trial drug
Pregnant woman or a lactating woman
A person who has serious mental disabilities
A person who requires the administration of drugs prohibited from concomitant use
A person who is administered another investigational drug or has been provided witha clinical trial medical device within 6 months prior to participating in a clinicaltrial
The person whom the investigator determines to be unsuitable for this study
Study Design
Connect with a study center
Seoul National University Hospital
Seoul,
Korea, Republic ofSite Not Available
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