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

September 10, 2015 updated by: CTC Bio, Inc.

A Prospective, Randomized, Single-blinded (Evaluator), 3-treatment Arm, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of CDFR0612 and CDFR0613

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

310

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of, 15355
        • Korea University Ansan Hospital
    • Gyeonggi
      • Uijengbu-si, Gyeonggi, Korea, Republic of, 480-717
        • Uijengbu St.Mary's Hospital
    • Seocho-gu, Banpo-daero
      • Seoul, Seocho-gu, Banpo-daero, Korea, Republic of, 222
        • Seoul St.Mary's Hospital
    • Seoul
      • Seongbuk-gu, Seoul, Korea, Republic of, 136-705
        • Korea University Anam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.
Active Comparator: 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
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.
Other Names:
  • Moviprep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful cleansing rate
Time Frame: post-colonoscopy at Day 2
%Patient with HCS-graded A or B
post-colonoscopy at Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall cleansing rate
Time Frame: post-colonoscopy at Day 2
%Patient with each HCS-grade (A, B, C, D)
post-colonoscopy at Day 2
Mean segmental cleansing score
Time Frame: post-colonoscopy at Day 2
5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.
post-colonoscopy at Day 2
Patient reported outcomes
Time Frame: Post-dosing at Day 1 and Day 2
Patient questionnaire about any patient discomfort related to study drug administration
Post-dosing at Day 1 and Day 2
Cecal intubation rate
Time Frame: post-colonoscopy at Day 2
post-colonoscopy at Day 2
Mean cecal intubation time
Time Frame: post-colonoscopy at Day 2
post-colonoscopy at Day 2
Mean colonoscopy withdrawal time
Time Frame: post-colonoscopy at Day 2
post-colonoscopy at Day 2
Treatment Compliance
Time Frame: Post dosing at Day 2
Post dosing at Day 2
Polyp detection rate
Time Frame: post-colonoscopy at Day 2
post-colonoscopy at Day 2

Other Outcome Measures

Outcome Measure
Time Frame
Treatment-emergent adverse events
Time Frame: For 4 weeks after treatment
For 4 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CTC Bio, Inc.

Collaborators

Symyoo

Investigators

  • Principal Investigator: Sang-Woo KIM, M.D., Seoul St. Mary's Hospital
  • Study Director: Dongjin Yoo, M.D., Symyoo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

November 27, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

September 10, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC-BCS-CDFR0612/0613_3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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