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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02304523
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : September 11, 2015
Sponsor:
Collaborator:
Symyoo
Information provided by (Responsible Party):
CTC Bio, Inc.

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.

Condition or disease Intervention/treatment Phase
Colonoscopy Preparation Colon Disease Drug: CDFR0612 Drug: CDFR0613 Drug: Coolprep Powder Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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 Name: Moviprep




Primary Outcome Measures :
  1. Successful cleansing rate [ Time Frame: post-colonoscopy at Day 2 ]
    %Patient with HCS-graded A or B


Secondary Outcome Measures :
  1. Overall cleansing rate [ Time Frame: post-colonoscopy at Day 2 ]
    %Patient with each HCS-grade (A, B, C, D)

  2. Mean segmental cleansing score [ Time Frame: post-colonoscopy at Day 2 ]
    5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.

  3. Patient reported outcomes [ Time Frame: Post-dosing at Day 1 and Day 2 ]
    Patient questionnaire about any patient discomfort related to study drug administration

  4. Cecal intubation rate [ Time Frame: post-colonoscopy at Day 2 ]
  5. Mean cecal intubation time [ Time Frame: post-colonoscopy at Day 2 ]
  6. Mean colonoscopy withdrawal time [ Time Frame: post-colonoscopy at Day 2 ]
  7. Treatment Compliance [ Time Frame: Post dosing at Day 2 ]
  8. Polyp detection rate [ Time Frame: post-colonoscopy at Day 2 ]

Other Outcome Measures:
  1. Treatment-emergent adverse events [ Time Frame: For 4 weeks after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304523


Locations
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Korea, Republic of
Uijengbu St.Mary's Hospital
Uijengbu-si, Gyeonggi, Korea, Republic of, 480-717
Seoul St.Mary's Hospital
Seoul, Seocho-gu, Banpo-daero, Korea, Republic of, 222
Korea University Anam Hospital
Seongbuk-gu, Seoul, Korea, Republic of, 136-705
Korea University Ansan Hospital
Ansan, Korea, Republic of, 15355
Sponsors and Collaborators
CTC Bio, Inc.
Symyoo
Investigators
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Principal Investigator: Sang-Woo KIM, M.D. Seoul St. Mary's Hospital
Study Director: Dongjin Yoo, M.D. Symyoo
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Responsible Party: CTC Bio, Inc.
ClinicalTrials.gov Identifier: NCT02304523    
Other Study ID Numbers: CTC-BCS-CDFR0612/0613_3
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015
Keywords provided by CTC Bio, Inc.:
Colonoscopy preparation
Bowel cleansing
Colon cleansing
Colonoscopy
CDFR0612
CDFR0613
Additional relevant MeSH terms:
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Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases