A Phase 3 Trial in Bowel Preparation for Colonoscopy

Taejoon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Bowel Preparation

Treatments: Drug: Cool prep; Drug: CTP0301-A; Drug: CTP0301-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT05870553

CTP0301

Details and patient eligibility

About

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

Enrollment: 137 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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137 participants in 3 patient groups

CTP0301-A

Experimental group

Description:

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

Treatment:

Drug: CTP0301-A

CTP0301-B

Experimental group

Description:

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

Treatment:

Drug: CTP0301-B

Cool prep

Active Comparator group

Description:

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

Treatment:

Drug: Cool prep