A Phase 3 Trial in Bowel Preparation for Colonoscopy

NCT ID: NCT05870553

Last Updated: 2024-02-28

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

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2023-05-12

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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CTP0301-A

Subjects who are randomized into this group will take CTP0301-A from the evening before colonoscopy to the morning of colonoscopy.

Group Type EXPERIMENTAL

CTP0301-A

Intervention Type DRUG

Bowel Preparation

CTP0301-B

Subjects who are randomized into this group will take CTP0301-B before the morning of colonoscopy.

Group Type EXPERIMENTAL

CTP0301-B

Intervention Type DRUG

Bowel Preparation

Cool prep

Subjects who are randomized into this group will take Cool prep from the evening before colonoscopy to the morning of colonoscopy.

Group Type ACTIVE_COMPARATOR

Cool prep

Intervention Type DRUG

Bowel Preparation

Interventions

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CTP0301-A

Bowel Preparation

Intervention Type DRUG

CTP0301-B

Bowel Preparation

Intervention Type DRUG

Cool prep

Bowel Preparation

Intervention Type DRUG

Other Intervention Names

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PEG 3350 PEG 3350 PEG 3350

Eligibility Criteria

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Inclusion Criteria

* Male and female outpatients and inpatients aged: ≥19
* A prospective colonoscopy person
* Written informed consent to participate in the trial

Exclusion Criteria

* Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
* Patients with ongoing severe acute Inflammatory Bowel Disease.
* Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy.
* Pregnant women or pregnant women or pregnant women
* Severe heart disease (cardiac failure (NYHA class 3 and 4))
* Acute coronary artery disease within 24 weeks before screening (an unstable angina pectoris, acute myocardial infarction), clinically significant arrhythmia, hypertrophic obstruction Cardiomyopathy, valvular disease, aortic and peripheral vascular diseases.
* People who have hypersensitivity or allergies to clinical trial drug components.
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 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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CTP0301

Identifier Type: -

Identifier Source: org_study_id

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