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

Primary Purpose

Colonoscopy Preparation, Colon Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CDFR0612
CDFR0613
Coolprep Powder
Sponsored by
CTC Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonoscopy Preparation focused on measuring Colonoscopy preparation, Bowel cleansing, Colon cleansing, Colonoscopy, CDFR0612, CDFR0613

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uijengbu St.Mary's Hospital
  • Seoul St.Mary's Hospital
  • Korea University Anam Hospital
  • Korea University Ansan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Test 1

Test 2

Comparator

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Successful cleansing rate
%Patient with HCS-graded A or B

Secondary Outcome Measures

Overall cleansing rate
%Patient with each HCS-grade (A, B, C, D)
Mean segmental cleansing score
5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.
Patient reported outcomes
Patient questionnaire about any patient discomfort related to study drug administration
Cecal intubation rate
Mean cecal intubation time
Mean colonoscopy withdrawal time
Treatment Compliance
Polyp detection rate

Full Information

First Posted
November 27, 2014
Last Updated
September 10, 2015
Sponsor
CTC Bio, Inc.
Collaborators
Symyoo
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1. Study Identification

Unique Protocol Identification Number
NCT02304523
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CTC Bio, Inc.
Collaborators
Symyoo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy Preparation, Colon Disease
Keywords
Colonoscopy preparation, Bowel cleansing, Colon cleansing, Colonoscopy, CDFR0612, CDFR0613

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Test 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CDFR0612
Intervention Description
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
Intervention Name(s)
CDFR0613
Intervention Description
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
Intervention Name(s)
Coolprep Powder
Other Intervention Name(s)
Moviprep
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful cleansing rate
Description
%Patient with HCS-graded A or B
Time Frame
post-colonoscopy at Day 2
Secondary Outcome Measure Information:
Title
Overall cleansing rate
Description
%Patient with each HCS-grade (A, B, C, D)
Time Frame
post-colonoscopy at Day 2
Title
Mean segmental cleansing score
Description
5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.
Time Frame
post-colonoscopy at Day 2
Title
Patient reported outcomes
Description
Patient questionnaire about any patient discomfort related to study drug administration
Time Frame
Post-dosing at Day 1 and Day 2
Title
Cecal intubation rate
Time Frame
post-colonoscopy at Day 2
Title
Mean cecal intubation time
Time Frame
post-colonoscopy at Day 2
Title
Mean colonoscopy withdrawal time
Time Frame
post-colonoscopy at Day 2
Title
Treatment Compliance
Time Frame
Post dosing at Day 2
Title
Polyp detection rate
Time Frame
post-colonoscopy at Day 2
Other Pre-specified Outcome Measures:
Title
Treatment-emergent adverse events
Time Frame
For 4 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Woo KIM, M.D.
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dongjin Yoo, M.D.
Organizational Affiliation
Symyoo
Official's Role
Study Director
Facility Information:
Facility Name
Uijengbu St.Mary's Hospital
City
Uijengbu-si
State/Province
Gyeonggi
ZIP/Postal Code
480-717
Country
Korea, Republic of
Facility Name
Seoul St.Mary's Hospital
City
Seoul
State/Province
Seocho-gu, Banpo-daero
ZIP/Postal Code
222
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seongbuk-gu
State/Province
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Ansan
ZIP/Postal Code
15355
Country
Korea, Republic of

12. IPD Sharing Statement

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

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