Clinical trial

A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy

Name

CTP0302

Description

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

Trial arms

Trial start

2023-08-29

Estimated PCD

2024-01-17

Trial end

2024-05-14

Status

Active (not recruiting)

Phase

Early phase I

Treatment

CTP0302-A

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

Arms:

CTP0302-A

Other names:

Treatment Group A

CTP0302-B

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

Arms:

CTP0302-B

Other names:

Treatment Group B

Conventional OST

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

Arms:

Conventional OST

Other names:

Control group

Size

161

Primary endpoint

Ratio of subjects With successful Bowel Cleansing

1 day of scheduled colonoscopy

Eligibility 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 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 161, 'type': 'ACTUAL'}}

Updated at

2024-03-01

1 organization

3 products

1 indication

Organization

Taejoon Pharmaceutical

Product

Indication

Product

Product