Safety and Efficacy of CDFR0612 and CDFR0613 for Bowel Cleansing Before Colonoscopy

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CTC Bio, Inc.
• Collaborator: Symyoo

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