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

Colon Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304523
• Other study ID #: CTC-BCS-CDFR0612/0613_3
• Status: Completed
• Phase: Phase 3
• First received: November 27, 2014
• Last updated: September 10, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: CTC Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Disease
• Colonic Diseases
• Colonoscopy Preparation

Intervention

Drug:
• CDFR0612
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.
• CDFR0613
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.
• Coolprep 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Korea University Anam Hospital	Seongbuk-gu	Seoul
Korea, Republic of	Seoul St.Mary's Hospital	Seoul	Seocho-gu, Banpo-daero
Korea, Republic of	Uijengbu St.Mary's Hospital	Uijengbu-si	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
CTC Bio, Inc.	Symyoo

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment-emergent adverse events		For 4 weeks after treatment	Yes
Primary	Successful cleansing rate	%Patient with HCS-graded A or B	post-colonoscopy at Day 2	No
Secondary	Overall cleansing rate	%Patient with each HCS-grade (A, B, C, D)	post-colonoscopy at Day 2	No
Secondary	Mean segmental cleansing score	5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.	post-colonoscopy at Day 2	No
Secondary	Patient reported outcomes	Patient questionnaire about any patient discomfort related to study drug administration	Post-dosing at Day 1 and Day 2	No
Secondary	Cecal intubation rate		post-colonoscopy at Day 2	No
Secondary	Mean cecal intubation time		post-colonoscopy at Day 2	No
Secondary	Mean colonoscopy withdrawal time		post-colonoscopy at Day 2	No
Secondary	Treatment Compliance		Post dosing at Day 2	No
Secondary	Polyp detection rate		post-colonoscopy at Day 2	No