Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation
NCT ID: NCT01745835
Last Updated: 2018-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
196 participants
INTERVENTIONAL
2013-01-30
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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2L Coolprep®
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
1L Coolprep® and Bisacodyl
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
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* between the age of 20 and 75 years
* healthy persons planning to have a colonoscopy
Exclusion Criteria
* 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
20 Years
75 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jong Pil Im, M.D.,Ph.D.
Role: STUDY_DIRECTOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, City, South Korea
Countries
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References
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Kwon JE, Lee JW, Im JP, Kim JW, Kim SH, Koh SJ, Kim BG, Lee KL, Kim SG, Kim JS, Jung HC. 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. 2016 Sep 2;11(9):e0162051. doi: 10.1371/journal.pone.0162051. eCollection 2016.
Other Identifiers
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Coolprep study
Identifier Type: -
Identifier Source: org_study_id
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