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A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03544944
Recruitment Status : Completed
First Posted : June 4, 2018
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Taejoon Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.

Condition or disease Intervention/treatment Phase
Bowel Preparation Drug: TJP-008-1 Drug: TJP-008-2 Drug: Coolprep powder Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy
Actual Study Start Date : January 2, 2018
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: TJP-008-1 Drug: TJP-008-1
Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day.
Experimental: TJP-008-2 Drug: TJP-008-2
Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning.
Active Comparator: Coolprep powder Drug: Coolprep powder
Subjects who are randomized into group Coolprep will receive bowel preparation from evening to next morning.


Outcome Measures
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Primary Outcome Measures :
  1. Ratio of subjects With successful Bowel Cleansing [ Time Frame: 1 day of scheduled colonoscopy ]

Secondary Outcome Measures :
  1. Easch segments ratio of subject with successful Bowel Cleansing [ Time Frame: 1 day of scheduled colonoscopy ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must provide written informed consent.
  • Male and female outpatients and inpatients aged: ≥19
  • Patients BMI shoule be ≤ 30

Exclusion Criteria:

  • Patients with past history within last 12 months or current episode of severe constipation
  • Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Known phenylketonuria.
  • Clinically relevant findings on physical examination based on the Investigator's judgment.
Contacts and Locations
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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): NCT03544944


Locations
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Korea, Republic of
Taejoon Pharmaceutical Co., Ltd.
Seoul, Korea, Republic of
Sponsors and Collaborators
Taejoon Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Taejoon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03544944    
Other Study ID Numbers: TJP-008-301
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taejoon Pharmaceutical Co., Ltd.:
bowel preparation