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Colonoscopy PreparationPhase 3NCT02304523

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

A Phase 3 study testing CDFR0612, CDFR0613 and Coolprep Powder in people with Colonoscopy Preparation and Colon Disease, run by CTC Bio, Inc. at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Colonoscopy Preparation, Colon Disease
What is being tested?
CDFR0612, CDFR0613 and Coolprep Powder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
4 sitesSouth Korea
Study dates
Jan 2015to Sep 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Korea University Ansan Hospital

    Ansan, 15355

  • Korea University Anam Hospital

    Seongbuk-gu, Seoul, 136-705

  • Seoul St.Mary's Hospital

    Seoul, Seocho-gu, Banpo-daero, 222

  • Uijengbu St.Mary's Hospital

    Uijengbu-si, Gyeonggi-do, 480-717

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
CDFR0612, CDFR0613, Coolprep Powder
Keywords
Colonoscopy preparation, Bowel cleansing, Colon cleansing, Colonoscopy, CDFR0612, CDFR0613
Medical subject headings
Colonic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CDFR0612Drug

    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.

  • CDFR0613Drug

    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.

  • Coolprep PowderDrug

    Also called Moviprep

    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.

Study groups in NCT02304523
Study groupRoleWhat they receive
Test 1ExperimentalCDFR0612 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.
Receives: Drug: CDFR0612
Test 2ExperimentalCDFR0613 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.
Receives: Drug: CDFR0613
ComparatorActive comparatorCoolprep 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.
Receives: Drug: Coolprep Powder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful cleansing rate

    %Patient with HCS-graded A or B

    Measured: post-colonoscopy at Day 2

Secondary outcomes (8)

  1. Overall cleansing rate

    %Patient with each HCS-grade (A, B, C, D)

    Measured: post-colonoscopy at Day 2

  2. Mean segmental cleansing score

    5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.

    Measured: post-colonoscopy at Day 2

  3. Patient reported outcomes

    Patient questionnaire about any patient discomfort related to study drug administration

    Measured: Post-dosing at Day 1 and Day 2

  4. Cecal intubation rate

    Measured: post-colonoscopy at Day 2

  5. Mean cecal intubation time

    Measured: post-colonoscopy at Day 2

  6. Mean colonoscopy withdrawal time

    Measured: post-colonoscopy at Day 2

  7. Treatment Compliance

    Measured: Post dosing at Day 2

  8. Polyp detection rate

    Measured: post-colonoscopy at Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionAug 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02304523
Sponsor's protocol ID
CTC-BCS-CDFR0612/0613_3
Status last verified
Sep 2015
First submitted
27 Nov 2014
Last updated
11 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CDFR0612, CDFR0613 and Coolprep Powder in people with Colonoscopy Preparation and Colon Disease, run by CTC Bio, Inc. at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful cleansing rate (time frame: post-colonoscopy at Day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02304523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2015.

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