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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2018-07-30

Brief Summary

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

Detailed Description

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Conditions

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Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TJP-008-1

Group Type EXPERIMENTAL

TJP-008-1

Intervention Type DRUG

Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day.

TJP-008-2

Group Type EXPERIMENTAL

TJP-008-2

Intervention Type DRUG

Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning.

Coolprep powder

Group Type ACTIVE_COMPARATOR

Coolprep powder

Intervention Type DRUG

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.

Intervention Type DRUG

TJP-008-2

Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning.

Intervention Type DRUG

Coolprep powder

Subjects who are randomized into group Coolprep will receive bowel preparation from evening to next morning.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taejoon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taejoon Pharmaceutical Co., Ltd.

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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TJP-008-301

Identifier Type: -

Identifier Source: org_study_id

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