safety and efficacy of cdfr0612 and cdfr0613 for bowel cleansing before colonoscopy

Conditions: Colonoscopy Preparation; Colon Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of cdfr0612 and cdfr0613 compared to peg+picosulfate (coolprep powder) preparation. the effectiveness for bowel cleansing will be assessed with harefield cleansing scale (hcs) by blinded assessor.

this study is a prospective, randomized, single-blinded, parallel, 3-treatment, multi-center clinical trial. a total of 297 subjects scheduled for colonoscopy will participate to this study and be assigned to 3 groups - cdfr0612, cdfr0613, or a comparator (coolprep powder). a subject will admit to hospital one day before colonoscopy and be administrated with study drug. in early morning at the that day of colonoscopy, he/she will be administrated with study drug again. any subject will be carefully monitored for safety during hospitalisation (1 night) and additional 4 weeks follow-up period because this study is the first human trial of cdfr0612 and cdfr0613.

Eligibility criteria:
inclusion criteria: * patients who is informed and give a consent in voluntary * patients who is scheduled a colonoscopy * bmi 19≤ and \<30 exclusion criteria: * patients who participate in other interventional study or had participated within 30 days before screening * pregnant or breast-feeding women who do not want to stop breast-feeding * women of childbearing potential who do not agree with appropriate contraception during this study * patients who had experienced any hypersensitivity study drug or ingredient * uncontrolled hypertension * arrhythmia with clinically significant findings from ekg * congestive heart failure; nyha functional class iii or iv; unstable coronary artery disease; myocardiac infarction history within 6 months * uncontrolled diabetes * active infection except acute upper respiratory infection or local skin infection; fever (38 °c and higher) within 1 week before study administration * hiv infection and/or chronic hepatitis b or c * patients who has a difficulty to participate because of severe nausea or vomiting * suspected or confirmed inflammatory bowel disease, toxic colon or toxic megacolon, or gastrointestinal obstruction or perforation; visible bleeding in colon * history of colon surgery and abdominal surgery within 6 month; need an emergency surgery * colonoscopy for the following use: treatment of bleeding from such lesions as vascular malformation, ulceration, neoplasia, and polypectomy site (e.g.,electrocoagulation, heater probe, laser or injection therapy); foreign body removal; decompression of acute nontoxic megacolon or sigmoid volvulus; balloon dilation of stenotic lesions (e.g., anastomotic strictures); palliative treatment of stenosing or bleeding neoplasms (e.g., laser, electrocoagulation, stenting) * fluid or electrolyte (na, k, ca, mg, chloride, bicarbonate) disturbance * severe dehydration risk (e.g., rhabdomyolysis, ascites) * dialysis or renal disorder (creatinine clearance \<15ml/min) * suspected pulmonary aspiration or gag reflex disorder * history of hypersensitivity of drug or others * alcohol or drug abuse within 6 months * clinically significant underlying disease or medical history at investigator's discretion * inability in written/verbal communication

Keywords: colonoscopy preparation bowel cleansing colon cleansing colonoscopy cdfr0612 cdfr0613