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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01745835
First received: November 27, 2012
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Healthy Person
Bowel Preparation Before Colonoscopy
Drug: 2L Coolprep®
Drug: 1L Coolprep® and Bisacodyl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation for Colonoscopy

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Bowel cleansing scale [ Time Frame: on the day of the colonoscopy ] [ Designated as safety issue: Yes ]
    using SNUH scale


Secondary Outcome Measures:
  • Bowel cleansing scale of Right/Transverse/Left colon [ Time Frame: on the day of the colonoscopy ] [ Designated as safety issue: Yes ]
    also using SNUH scale


Other Outcome Measures:
  • Patient's compliance [ Time Frame: on the day of the colonoscopy ] [ Designated as safety issue: Yes ]
    using questionnaires

  • Patient's acceptance [ Time Frame: on the day of the colonoscopy ] [ Designated as safety issue: Yes ]
    using questionnare

  • Patient's satisfaction [ Time Frame: on the day of the colonoscopy ] [ Designated as safety issue: Yes ]
    using questionnaires


Estimated Enrollment: 196
Study Start Date: January 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745835

Contacts
Contact: Jong Pil Im, M.D. 82-2-740-8112 jp-im@hanmail.net
Contact: Ji Eun Kwon, M.D. 82-10-5060-0600 pray4u0226@hotmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, City, Korea, Republic of
Contact: Jong Pil Im, M.D., Ph.D.    82-2-740-8112    jp-im@hanmail.net   
Contact: Ji Eun Kwon, M.D.    82-10-5060-0600    pray4u0226@hotmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Jong Pil Im, M.D.,Ph.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01745835     History of Changes
Other Study ID Numbers: Coolprep study
Study First Received: November 27, 2012
Last Updated: May 3, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014