← Back to all trials
Recruiting
NCT05670470
A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial
Conditions: Bowel Preparation
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: 1
Phase: PHASE3
Enrollment: 85
Sponsor: Taejoon Pharmaceutical Co., Ltd.
Location: Korea, Republic of
Summary
This is a prospective randomized study compared with active control arm.
Eligibility Criteria
Inclusion Criteria:Male and female outpatients and inpatients aged: ≥19A prospective colonoscopy personWritten informed consent to participate in the trialExclusion 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 DiseasePatients 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 womenPatients who have not been confirmed to have COVID-19 for a monthSevere 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 diseasesPatients 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
Source: ClinicalTrials.gov (NCT05670470). StuddyBuddy aggregates publicly available trial information.