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

This study is currently recruiting participants.
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
History of Changes
  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:

Drug Information available for: Bisacodyl
U.S. FDA Resources

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
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 May 22, 2013