Phase
Condition
Colon Cancer Screening
Treatment
DWJ1609
DWC202304
Clinical Study ID
Ages > 19 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult men and women 19 years of age or older as of the date of consent in writing
a prospective colonoscopy patient
19 kg/㎡ ≤ BMI < 30 kg/㎡
A person who voluntarily agrees to participate in this clinical trial and signs awritten agreement Abbreviation: BMI = body mass index
Exclusion
Exclusion Criteria:
A person who undergoes colonoscopy for the following therapeutic purposes (1)balloon dilatation of the stenosis area (2) non-toxic giant colon or decompressionof the S-phase colitis (sigmoid volvulus) (3) Removal of foreign substances (4)Vascular dysplasia, ulcer, tumor and treatment of bleeding after polypectomy (5)Treatment for stenosis or tumor bleeding (palliative treatment)
A person whose past history has been confirmed during a screening visit (1) Severeheart disease (insecurity angina, acute myocardial infarction, acute heart failure,cardiomyopathy, etc.) or acute respiratory failure within 24 weeks prior toscreening (2) Epilepsy or seizures within 96 weeks prior to screening (3) Clinicallysignificant intestinal surgical history regardless of duration (e.g., colonpremature surgery, colon resection, etc.) a. However, appendectomy and hemorrhoids are excluded
A person who has been identified or suspected of the following comorbidities duringa screening visit (1) active intestinal hemorrhage (2) gastrointestinal obstruction (intestinal obstruction, gastrointestinal obstruction, etc.), gastrointestinalperforation, gastric discharge disorder (gastrointestinal paralysis, gastriccongestion, etc.) (3) Inflammatory bowel disease (ulcerative colitis, Crohn'sdisease, toxic colitis, toxic colitis, etc.) (4) Gastrointestinal ulcers, colorectalmucosal ulcers, ischemic colitis (5) an acute abdominal condition requiring surgery (6) A person who has been identified with the following major cardiovasculardiseases
① congestive heart failure
② NYHA functional classification III or IV
③ Clinically significant arrhythmia identified by ECG, QTcFb delay (Male > 450 msec,Female > 470 msec) etc. b. QTc interval corrected by Fridericia's formula (7) Despite adequate medication,uncontrolled hypertension (SBP > 170 mmHg and DBP > 100 mmHg) (8) Diabetesundergoing insulin treatment or in need of insulin treatment (9) Clinicallysignificant electrolyte abnormalities (sodium, potassium, calcium, magnesium,chloride, bicarbonate, phosphate etc.) (10) Those who are at risk of dehydration (transverse fusion, ascites, etc.) (11) Severe renal impairment (eGFRc < 30mL/min/1.73m2) c. MDRD-eGFR (mL/min/1.73m2) = 186 × (serum creatinineconcentration)-1.154 × (age)-0.203 (× 0.742, Female) (12) Child-Pugh class B or C (13) ALT or AST > three times the normal upper limit of the trachea (14) Severenausea or vomiting that makes it difficult to participate in clinical trials (15)Active infection or high fever above 38℃ (except acute upper respiratory tractinfection or local skin infection) (16) Active hepatitis B or C d. Defined as HBsAgpositive during screening e. Defined as HCV Ab positive during screening (17) Testresults of HIV antibodies and antibody test results
- A person who is administering the following drugs during a screening visit or isexpected to be administered by the time of completion of a colonoscopy (Day 2; Visit
- (1) Constipation patients who are regularly administered laxatives orgastrointestinal motility promoters within 12 weeks prior to screening (e.g., two tothree times a week or more) (2) Administration of laxatives, enema, simethicone, 5HT4 receptor agonist, iron preparation, opioid excluding clinical trial drugswithin 7 days of clinical trial drug administration (Day 1)
A person who is hypersensitive to the ingredients of a clinical trial drug
a pregnant woman or a lactating woman
Fertility women and men who have a pregnancy plan or do not agree to performappropriate contraception during the clinical trial. Appropriate contraception inthis trial is as follows
hormonal contraceptive
implantation of intrauterine device or intrauterine system
Infertility procedures/surgery (e.g., bilateral ovarian ligation, vasectomy)
A person who has participated in another clinical trial/medical device clinicaltrial within 4 weeks of screening and has received/treated clinical trialmedication/medical device
For other reasons, the tester determines that he/she is unfit to be tested for thisclinical trial (e.g., clinically significant blood coagulation disorder, mentalillness, dementia, drug or alcohol abuse history, oral administration of clinicaltrial drugs)
Study Design
Study Description
Connect with a study center
Kangbuk Samsung Hospital
Seoul, Korea,
Korea, Republic ofSite Not Available
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