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

NCT02304523 | Completed Phase 3

• 1 other identifier: CTC-BCS-CDFR0612/0613_3
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 4

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.

Conditions

Colonoscopy Preparation; Colon Disease

Keywords

Colonoscopy preparation; Bowel cleansing; Colon cleansing; Colonoscopy; CDFR0612; CDFR0613

Outcome Measures

Primary Outcomes (1)

• Successful cleansing rate

  %Patient with HCS-graded A or B

  post-colonoscopy at Day 2

Secondary Outcomes (8)

• Overall cleansing rate

  post-colonoscopy at Day 2

• Mean segmental cleansing score

  post-colonoscopy at Day 2

• Patient reported outcomes

  Post-dosing at Day 1 and Day 2

• Cecal intubation rate

  post-colonoscopy at Day 2

• Mean cecal intubation time

  post-colonoscopy at Day 2

Other Outcomes (1)

• Treatment-emergent adverse events

  For 4 weeks after treatment

Study Arms (3)

Test 1

EXPERIMENTAL

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.

Drug: CDFR0612

Test 2

EXPERIMENTAL

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.

Drug: CDFR0613

Comparator

ACTIVE 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.

Drug: Coolprep Powder

Interventions

CDFR0612 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 1

CDFR0613 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.

Test 2

Coolprep Powder 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.

Also known as: Moviprep

Comparator

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who is informed and give a consent in voluntary
• Patients who is scheduled a colonoscopy
• BMI 19≤ and \<30

You may not qualify if:

• 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

Sponsors & Collaborators

• CTC Bio, Inc.: lead
• Symyoo: collaborator

Study Sites (4)

Uijengbu St.Mary's Hospital

Uijengbu-si, Gyeonggi-do, 480-717, South Korea

Location

Seoul St.Mary's Hospital

Seoul, Seocho-gu, Banpo-daero, 222, South Korea

Location

Korea University Anam Hospital

Seongbuk-gu, Seoul, 136-705, South Korea

Location

Korea University Ansan Hospital

Ansan, 15355, South Korea

Location

MeSH Terms

Conditions

Colonic Diseases

Interventions

MoviPrep

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Sang-Woo KIM, M.D.

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Dongjin Yoo, M.D.

  Symyoo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 2, 2014
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 11, 2015

Record last verified: 2015-09

Locations

KR (4)