A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy
NCT ID: NCT03544944
Last Updated: 2019-09-04
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
297 participants
INTERVENTIONAL
2018-01-02
2018-07-30
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
TREATMENT
SINGLE
Study Groups
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TJP-008-1
TJP-008-1
Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day.
TJP-008-2
TJP-008-2
Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning.
Coolprep powder
Coolprep powder
Subjects who are randomized into group Coolprep will receive bowel preparation from evening to next morning.
Interventions
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TJP-008-1
Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day.
TJP-008-2
Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning.
Coolprep powder
Subjects who are randomized into group Coolprep will receive bowel preparation from evening to next morning.
Eligibility Criteria
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Inclusion Criteria
* Male and female outpatients and inpatients aged: ≥19
* Patients BMI shoule be ≤ 30
Exclusion Criteria
* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* Known phenylketonuria.
* Clinically relevant findings on physical examination based on the Investigator's judgment.
18 Years
ALL
Yes
Sponsors
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Taejoon Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Taejoon Pharmaceutical Co., Ltd.
Seoul, , South Korea
Countries
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Other Identifiers
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TJP-008-301
Identifier Type: -
Identifier Source: org_study_id
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