Comparison of Polyethylene Glycol With Ascorbic Acid and Oral Sulfate Solution for Bowel Preparation
NCT ID: NCT02551198
Last Updated: 2019-01-17
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
184 participants
INTERVENTIONAL
2015-11-01
2017-09-01
Brief Summary
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For bowel preparation, effective, well-tolerated and safe methods should be applied.
Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel preparation
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HAPREP® (PEG-Asc)
subjects randomized to 2L polyethylene glycol with ascorbic acid (PEG-Asc) were instructed to use PEG-Asc for bowel preparation
: PEG-Asc(500mLx2 times q30min)\[PM 7-9, the day before colonoscopy\] + PEG-Asc(500mLx2 times q30min)\[AM 5-7, the day of colonoscopy\]
HAPREP®
Arm1: HAPREP® (2L polyethylene glycol with ascorbic acid; PEG-Asc)
: : PEG-Asc(500mLx2 times q30min)\[PM 7-9, the day before colonoscopy\] + PEG-Asc(500mLx2 times q30min)\[AM 5-7, the day of colonoscopy\]
SUCLEAR® (OSS)
subjects randomized to oral sulfate solution were instructed to use oral sulfate solution (OSS) for bowel preparation
: OSS(1b/177mL)\[PM 7-9, the day before colonoscopy\] + OSS(1b/177mL)\[AM 5-7, the day of colonoscopy\]
SUCLEAR®
Arm2: SUCLEAR® (oral sulfate solution; OSS): OSS(1b/177mL)\[PM 7-9, the day before colonoscopy\] + OSS(1b/177mL)\[AM 5-7, the day of colonoscopy\]
Interventions
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HAPREP®
Arm1: HAPREP® (2L polyethylene glycol with ascorbic acid; PEG-Asc)
: : PEG-Asc(500mLx2 times q30min)\[PM 7-9, the day before colonoscopy\] + PEG-Asc(500mLx2 times q30min)\[AM 5-7, the day of colonoscopy\]
SUCLEAR®
Arm2: SUCLEAR® (oral sulfate solution; OSS): OSS(1b/177mL)\[PM 7-9, the day before colonoscopy\] + OSS(1b/177mL)\[AM 5-7, the day of colonoscopy\]
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who were visited the outpatient clinic for National Cancer Cancer or Daehang hospital to undergo colonoscopy
Exclusion Criteria
* Bowel perforation
* Gastric retention
* Ileus
* Toxic colitis or toxic megacolon
* Known allergies to components of the OSS and PEG-Asc
* History of colorectal resection
* History of abdominopelvic surgery within 6 months
* uncontrolled electrolyte imbalance
* hereditary Phenylketonuria
* Severe dehydration status
* seizure
* coma
* Glucose-6-phosphate dehydrogenase deficiency
20 Years
75 Years
ALL
Yes
Sponsors
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Daehang Hospital
OTHER
National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Dae Kyung Sohn
M.D., PhD
Principal Investigators
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Dae Kyung Sohn, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center
Locations
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National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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NCC2015-0210
Identifier Type: -
Identifier Source: org_study_id
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