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

CTP0303

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

2022-09-21

2023-01-15

2023-01-31

Completed

Early phase I

84

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 84, 'type': 'ACTUAL'}}

2023-03-01