Colon Disease, Colonoscopy Preparation
Conditions
Keywords
Colonoscopy preparation, Bowel cleansing, Colon cleansing, Colonoscopy, CDFR0612, CDFR0613
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 assessed with Harefield Cleansing Scale (HCS) by blinded assessor.
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 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.
Interventions
DRUGCDFR0612
Preparation 500mL is a mixture of CDFR0612 150mL and water 350mL. A total of 2L (Preparation 1L and additional water 1L) will be administrated divided into two in evening before and in early morning at that day of colonoscopy.
DRUGCDFR0613
Preparation 500mL is a mixture of CDFR0613 150mL and water 350mL. A total of 2L (Preparation 1L and additional water 1L) will be administrated divided into two in evening before and in early morning at that day of colonoscopy.
DRUGCoolprep Powder
Preparation 500mL is a water solution of Coolprep Powder A and B. A total of 3L (Preparation 2L and additional water 1L) will be administrated divided into two in evening before and in early morning at that day of colonoscopy.
Sponsors
Symyoo
CTC Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful cleansing rate | post-colonoscopy at Day 2 | %Patient with HCS-graded A or B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall cleansing rate | post-colonoscopy at Day 2 | %Patient with each HCS-grade (A, B, C, D) |
| Mean segmental cleansing score | post-colonoscopy at Day 2 | 5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum. |
| Patient reported outcomes | Post-dosing at Day 1 and Day 2 | Patient questionnaire about any patient discomfort related to study drug administration |
| Cecal intubation rate | post-colonoscopy at Day 2 | — |
| Mean colonoscopy withdrawal time | post-colonoscopy at Day 2 | — |
| Treatment Compliance | Post dosing at Day 2 | — |
| Polyp detection rate | post-colonoscopy at Day 2 | — |
| Mean cecal intubation time | post-colonoscopy at Day 2 | — |
Other
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events | For 4 weeks after treatment |
Countries
South Korea
Outcome results
None listed