Status:
COMPLETED
Safety and Efficacy of CDFR0612 and CDFR0613 for Bowel Cleansing Before Colonoscopy
Lead Sponsor:
CTC Bio, Inc.
Collaborating Sponsors:
Symyoo
Conditions:
Colonoscopy Preparation
Colon Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief 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 asses...
Detailed Description
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 ass...
Eligibility Criteria
Inclusion
- Patients who is informed and give a consent in voluntary
- Patients who is scheduled a colonoscopy
- BMI 19≤ and \<30
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT02304523
Start Date
January 1 2015
End Date
September 1 2015
Last Update
September 11 2015
Active Locations (4)
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1
Uijengbu St.Mary's Hospital
Uijengbu-si, Gyeonggi-do, South Korea, 480-717
2
Seoul St.Mary's Hospital
Seoul, Seocho-gu, Banpo-daero, South Korea, 222
3
Korea University Anam Hospital
Seongbuk-gu, Seoul, South Korea, 136-705
4
Korea University Ansan Hospital
Ansan, South Korea, 15355