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

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ClinicalTrials.gov Identifier: NCT01745835
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Person Bowel Preparation Before Colonoscopy Drug: 2L Coolprep® Drug: 1L Coolprep® and Bisacodyl Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation for Colonoscopy
Actual Study Start Date : January 30, 2013
Actual Primary Completion Date : August 31, 2013
Actual Study Completion Date : January 31, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Bisacodyl
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. Bowel cleansing scale [ Time Frame: on the day of the colonoscopy ]
    using SNUH scale


Secondary Outcome Measures :
  1. Bowel cleansing scale of Right/Transverse/Left colon [ Time Frame: on the day of the colonoscopy ]
    also using SNUH scale


Other Outcome Measures:
  1. Patient's compliance [ Time Frame: on the day of the colonoscopy ]
    using questionnaires

  2. Patient's acceptance [ Time Frame: on the day of the colonoscopy ]
    using questionnare

  3. Patient's satisfaction [ Time Frame: on the day of the colonoscopy ]
    using questionnaires



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745835


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, City, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Jong Pil Im, M.D.,Ph.D. Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01745835     History of Changes
Other Study ID Numbers: Coolprep study
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: February 2017

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Laxatives