Clinical trial NCT02304523: Safety and Efficacy of CDFR0612 and CDFR0613 for Bowel Cleansing Before Colonoscopy
Official title: A Prospective, Randomized, Single-blinded (Evaluator), 3-treatment Arm, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of CDFR0612 and CDFR0613
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy Preparation
Colon Disease
Keywords: Colonoscopy preparation
Bowel cleansing
Colon cleansing
Colonoscopy
CDFR0612
CDFR0613
Lead sponsor: CTC Bio, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Symyoo
First posted: 2014-12-02
Enrollment: 310
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Successful cleansing rate
timeFrame: post-colonoscopy at Day 2
Secondary outcomes:
measure: Overall cleansing rate
timeFrame: post-colonoscopy at Day 2
measure: Mean segmental cleansing score
timeFrame: post-colonoscopy at Day 2
measure: Patient reported outcomes
timeFrame: Post-dosing at Day 1 and Day 2
measure: Cecal intubation rate
timeFrame: post-colonoscopy at Day 2
measure: Mean cecal intubation time
timeFrame: post-colonoscopy at Day 2
measure: Mean colonoscopy withdrawal time
timeFrame: post-colonoscopy at Day 2
measure: Treatment Compliance
timeFrame: Post dosing at Day 2
measure: Polyp detection rate
timeFrame: post-colonoscopy at Day 2
Other outcomes:
measure: Treatment-emergent adverse events
timeFrame: For 4 weeks after treatment
Locations:
city: Uijengbu-si
country: Korea, Republic of
facility: Uijengbu St.Mary's Hospital
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
state: Seocho-gu, Banpo-daero
city: Seongbuk-gu
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Sang-Woo KIM, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Symyoo
name: Dongjin Yoo, M.D.
role: STUDY_DIRECTOR
References: