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Comparison between 2L Coolprep® and Combination of 1L Coolprep® and bisacodyl as bowel preparation for colonoscopy

Status Approved

  • First Submitted Date

    2012/11/26

  • Registered Date

    2013/03/25

  • Last Updated Date

    2018/01/30

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0000708
    Unique Protocol ID H-1207-041-417
    Public/Brief Title Comparison between 2L Coolprep® and Combination of 1L Coolprep® and bisacodyl as bowel preparation for colonoscopy
    Scientific Title Comparison between 2L Coolprep® and Combination of 1L Coolprep® and bisacodyl as bowel preparation for colonoscopy
    Acronym Coolprep study
    MFDS Regulated Study Yes
    IND/IDE Protocol No
    Registered at Other Registry Yes
    Name of Registry / Registration Number ClinicalTrials.gov-NCT01745835
    Healthcare Benefit Approval Status

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number H-1207-041-417
    Approval Date 2012-08-17
    Institutional Review Board Name Seoul national university/Seoul national university hospital IRB (Institutional Review Board)
    Institutional Review Board Address 101 Daehak-ro, Jongno-gu, Seoul, Korea
    Institutional Review Board Telephone 02-2072-2263
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jong Pil Im
    Title M.D.
    Telephone +82-2-740-8112
    Affiliation Seoul National University Hospital
    Address 101 Daehak-ro, Jongno-gu, Seoul, Korea
    Contact Person for Public Queries
    Name Jong Pil Im
    Title M.D.
    Telephone +82-2-740-8112
    Affiliation Seoul National University Hospital
    Address 101 Daehak-ro, Jongno-gu, Seoul, Korea
    Contact Person for Updating Information
    Name Jong Pil Im
    Title M.D.
    Telephone +82-2-740-8112
    Affiliation Seoul National University Hospital
    Address 101 Daehak-ro, Jongno-gu, Seoul, Korea

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 2
    Overall Recruitment Status Completed
    Date of First Enrollment 2013-01-07 Actual
    Target Number of Participant 196
    Primary Completion Date 2013-08-31 , Actual
    Study Completion Date 2014-01-31 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Seoul National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2013-01-07 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2013-01-07 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Taejoon Pharm
    Organization Type Pharmaceutical Company
    Project ID H-1207-041-417

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Seoul National University Hospital
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    This study was designed to compare the efficacy and patient tolerance of bowel preparation using 2 liters of Coolprepⓡ (Coolprepⓡ consists of polyethylene glycol and ascorbic acid; Taejoon Pharm, Seoul, Korea) with  1 liter of Coolprepⓡ preceded by the stimulant laxative bisacodyl.

  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose 
    Diagnosis
    Phase Phase3
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Investigator
    Allocation RCT
    Intervention Type Drug  
    Intervention Description 
    1.Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea)
* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
2.Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) * composition /1 tablet : Bisacodyl 5mg, docusate sodium 16.75mg

□ Active Comparator: 2L Coolprep® group
As a bowel preparation before colonoscopy, they will take 2L of Coolprep®.

□ Experimental: 1L Coolprep® and Bisacodyl group
As a bowel preparation before colonoscopy, they will take 1L of Coolprep® and 20mg of Bisacodyl.
    Number of Arms 2
    Arm 1

    Arm Label

    2L Coolprep® group

    Target Number of Participant

    98

    Arm Type

    Active comparator

    Arm Description

    □ Active Comparator: 2L Coolprep® group
As a bowel preparation before colonoscopy, they will take 2L of Coolprep®.
(they will take 1L of Coolprep® on the evening before the exam.
 And then, they will take 1L of Coolprep® on the day of exam.)
    Arm 2

    Arm Label

    1L Coolprep® and Bisacodyl group

    Target Number of Participant

    98

    Arm Type

    Experimental

    Arm Description

    □ Experimental: 1L Coolprep® and Bisacodyl group
As a bowel preparation before colonoscopy, they will take 1L of Coolprep® and 20mg of Bisacodyl.
(they will take 20mg of Bisacodyl(4 tablets(20mg) of Dulcolax-Sⓡ) on the evening before the exam. And then, they will take 1L of Coolprep® on the day of exam.)

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (Z00-Z99)Factors influencing health status and contact with health services 
       (Z01.8)Other specified special examinations 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~75Year

    Description

    (1)willing to consent/undergo necessary procedures
(2)between the age of 20 and 75 years
(3)healthy persons planning to have a colonoscopy
    Exclusion Criteria 
    (1)history of abdominal surgery except appendectomy
(2)inflammatory bowel disease
(3)clinically or laboratory-confirmed ileus (both functional and mechanical)
(4)malignancy
(5)clinically severe cerebrovascular, cardiovascular, kidney, liver or hematologic disease
(6)dementia, cognitive impairment
(7)the use of prokinetics, antispasmodics, antidiarrheal drugs, laxatives or neuroleptics in 2 weeks
(8)known sensitivity to the agents used
(9)Pregnancy, Lactating woman
    Healthy Volunteers Yes

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome 
    bowel cleasing scale of whole colon
    Timepoint 
    on the day of the colonoscopy
    Secondary Outcome(s) 1
    Outcome 
    bowel cleasing scale of Right/Transverse/Left colon
    Timepoint 
    on the day of the colonoscopy
    Secondary Outcome(s) 2
    Outcome 
    Patient' acceptance, using questionnaires
    Timepoint 
    on the day of the colonoscopy
    Secondary Outcome(s) 3
    Outcome 
    Patient's compliance, using questionnaires
    Timepoint 
    on the day of the colonoscopy
    Secondary Outcome(s) 4
    Outcome 
    Patient's satisfaction, using questionnaires
    Timepoint 
    on the day of the colonoscopy

  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered Yes
    Published
    Results Upload
    Final Enrollment Number 187
    Number of Publication 1
    Publications 1 
    Ji Eun Kwon, Jung Won Lee, Jong Pil Im, Ji Won Kim,  SeongJoon Koh, Byeong Gwan Kim, Kook Lae Lee, Sang Gyun Kim,  Joo Sung Kim, Hyun Chae Jung. Comparable Efficacy of a 1-L PEG and Ascorbic Acid Solution Administered with Bisacodyl versus a 2-L PEG and Ascorbic Acid Solution for Colonoscopy Preparation: A Prospective, Randomized and Investigator-Blinded Trial.. PLOS ONE. SCI. 2016-09-02 ,
														 VOL : 11 page :  ~ 
														http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0162051
    Results Upload -participant flow.jpg
    Date of Posting Results 2013/03/25
    Protocol URL or File Upload
    Brief Summary 
    BACKGROUND:
Two liters of polyethylene glycol (PEG) solution administered with ascorbic acid (Asc) can provide efficacy similar to that of a 4-L PEG solution for colonoscopy preparation. In addition, oral bisacodyl (Bis) has been shown to reduce the volume of PEG needed for a bowel preparation with comparable efficacy. This study aimed to compare the efficacy, tolerability and safety of a 2-L PEG solution mixed with Asc versus the combination of Bis, Asc and a 1-L PEG solution.

METHODS:
This was a prospective, randomized, multi-centre, single-blind, non-inferiority trial. Participants who were scheduled for colonoscopy were included and randomized to receive either 2-L PEG and Asc (2L PEG/Asc group) or 1-L PEG, Asc and 20 mg Bis (1L PEG/Asc + Bis group). The quality of bowel preparation was assessed using the Boston Bowel Preparation Scale. Data regarding tolerance, compliance and adverse events were also gathered.

RESULTS:
A total of 187 participants were analyzed; 96 were allocated to the 2L PEG/Asc group and 91 to the 1L PEG/Asc + Bis group. Bowel preparation was adequate in 87.5% (84/96) of patients in the 2L PEG/Asc group and 94.5% of the 1L PEG/Asc + Bis group (86/91, p = 0.10). There was no significant difference between the two groups with respect to compliance, tolerability or safety. The patients allocated to the 1L PEG/Asc + Bis group expressed more willingness to repeat the procedure than patients in the 2L PEG/Asc group (p = 0.01).

CONCLUSIONS:
Bowel preparation with Bis and a 1-L PEG/Asc solution is as effective, well-tolerated, and safe as a 2-L PEG/Asc solution.

TRIAL REGISTRATION:
ClinicalTrials.gov NCT 01745835; Clinical Research Information Service (CRiS) KCT0000708.

  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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