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A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy

NCT ID: NCT06287606

Last Updated: 2024-11-29

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

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-29

Study Completion Date

2024-01-04

Brief Summary

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A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy

Detailed Description

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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.

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

DOUBLE

Investigators Outcome Assessors

Study Groups

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CTP0302-A

2 days split-dose

Group Type EXPERIMENTAL

CTP0302-A

Intervention Type DRUG

Subjects randomized into group CTP0302-A will take a bowel preparation from the evening until the following morning.

CTP0302-B

One day dose

Group Type EXPERIMENTAL

CTP0302-B

Intervention Type DRUG

Subjects randomized into group CTP0302-B will take a bowel preparation on the Colonoscopy day

Conventional OST

2 days split-dose

Group Type ACTIVE_COMPARATOR

Conventional OST

Intervention Type DRUG

Subjects randomized into group Conventional OST will take a bowel preparation from the evening until the following morning.

Interventions

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CTP0302-A

Subjects randomized into group CTP0302-A will take a bowel preparation from the evening until the following morning.

Intervention Type DRUG

CTP0302-B

Subjects randomized into group CTP0302-B will take a bowel preparation on the Colonoscopy day

Intervention Type DRUG

Conventional OST

Subjects randomized into group Conventional OST will take a bowel preparation from the evening until the following morning.

Intervention Type DRUG

Other Intervention Names

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Treatment Group A Treatment Group B Control group

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 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

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

Principal Investigators

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Jaemyung Cha, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Hospital at Gangdong

Locations

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Taejoon Pharmaceutical Co., Ltd.

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CTP0302

Identifier Type: -

Identifier Source: org_study_id