A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial (PROPELLER)

Taejoon Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Bowel Preparation

Treatments

Drug: CTP0303

Drug: Orafang Tab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05670470

CTP0303

Details and patient eligibility

About

This is a prospective randomized study compared with active control arm.

Full description

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

Enrollment

84 patients

Sex

All

Ages

19+ 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, Hartmann's procedure and defunctioning ileostomy or other similar surgeries involving structure and function of the small or large colon.
Pregnant women or pregnant women or pregnant women
Patients who have not been confirmed to have COVID-19 for a month
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
Patients with severe chronic renal impairment (glomerular filtration rate less than 30ml/min/1.73m2)
People who have hypersensitivity or allergies to clinical trial drug components