Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation

March 7, 2018 updated by: Seoul National University Hospital

Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation for Colonoscopy

comparison of the use of Colyte® (ascorbic acid mixed polyethylene glycol solution) in two-liter versus one-liter volume and pretreatment with bisacodyl for colonoscopy preparation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

196

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
    • City
      • Seoul, City, Korea, Republic of
        • Seoul National University 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

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • willing to consent/undergo necessary procedures
  • between the age of 20 and 75 years
  • healthy persons planning to have a colonoscopy

Exclusion Criteria:

  • history of abdominal surgery except appendectomy
  • inflammatory bowel disease
  • clinically or laboratory-confirmed ileus (both functional and mechanical)
  • malignancy
  • clinically severe cerebrovascular, cardiovascular, kidney, liver or hematologic disease
  • dementia, cognitive impairment
  • the use of prokinetics, antispasmodics, antidiarrheal drugs, laxatives or neuroleptics in 2 weeks
  • known sensitivity to the agents used
  • Pregnancy, Lactating woman

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2L Coolprep®
Drug: 2L Coolprep®
* 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
Other Names:
  • 2L Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea)
EXPERIMENTAL: 1L Coolprep® and Bisacodyl
Drug: 1L Coolprep® and Bisacodyl

  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
Other Names:
  • 1. Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 1L
  • 2. Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) : 4 tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel cleansing scale
Time Frame: on the day of the colonoscopy
using SNUH scale
on the day of the colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel cleansing scale of Right/Transverse/Left colon
Time Frame: on the day of the colonoscopy
also using SNUH scale
on the day of the colonoscopy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's compliance
Time Frame: on the day of the colonoscopy
using questionnaires
on the day of the colonoscopy
Patient's acceptance
Time Frame: on the day of the colonoscopy
using questionnare
on the day of the colonoscopy
Patient's satisfaction
Time Frame: on the day of the colonoscopy
using questionnaires
on the day of the colonoscopy

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Jong Pil Im, M.D.,Ph.D., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

January 30, 2013

Primary Completion (ACTUAL)

August 31, 2013

Study Completion (ACTUAL)

January 31, 2014

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (ESTIMATE)

December 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Coolprep study

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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