A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy.

CTP0301

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

2023-01-30

2023-05-12

2023-05-12

Completed

Early phase I

137

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 137, 'type': 'ACTUAL'}}

2024-02-28