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

NCT ID: NCT02304523

Last Updated: 2015-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-09-30

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.

Conditions

Colonoscopy Preparation; Colon Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test 1

CDFR0612 Solution 150mL will be mixed with water of 350ml to prepare a bowel cleansing preparation solution 500mL. Take it within 30min. After then, take additional water 500ml within 30min.

These processes will be in evening at one day before colonoscopy and in early morning at the same day of colonoscopy.

Group Type: EXPERIMENTAL

CDFR0612

Intervention Type: DRUG

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.

Test 2

CDFR0613 Solution 150mL will be mixed with water of 350ml to prepare a bowel cleansing preparation solution 500mL. Take it within 30min. After then, take additional water 500ml within 30min.

These processes will be in evening at one day before colonoscopy and in early morning at the same day of colonoscopy.

Group Type: EXPERIMENTAL

CDFR0613

Intervention Type: DRUG

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.

Comparator

Coolprep Powder A and B will be mixed with water to prepare a mixture of a bowel cleansing preparation solution 500mL. Repeat it twice. Take these of IL (2 * 500mL) within 1 hour. After then, take additional 500ml water.

These processes will be in evening at one day before colonoscopy and in early morning at the same day of colonoscopy.

Group Type: ACTIVE_COMPARATOR

Coolprep Powder

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Moviprep

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Symyoo

INDUSTRY

Sponsor Role: collaborator

CTC Bio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sang-Woo KIM, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Dongjin Yoo, M.D.

Role: STUDY_DIRECTOR

Symyoo

Locations

Uijengbu St.Mary's Hospital

Uijengbu-si, Gyeonggi-do, South Korea

Seoul St.Mary's Hospital

Seoul, Seocho-gu, Banpo-daero, South Korea

Korea University Anam Hospital

Seongbuk-gu, Seoul, South Korea

Korea University Ansan Hospital

Ansan, , South Korea

Countries

South Korea

Other Identifiers

CTC-BCS-CDFR0612/0613_3

Identifier Type: -

Identifier Source: org_study_id