Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)
Trial Parameters
Brief Summary
This is a study to test the non-inferiority of bowel cleansing with 100 g Mannitol against standard Plenvu® same-day dosing regimen. The 50% of the subjects will receive Mannitol, while the remaining part will receive Plenvu®.
Eligibility Criteria
Inclusion Criteria: 1. Ability of subject to consent and provide signed written informed consent. 2. Age ≥ 18 years. 3. Males and females scheduled for elective colonoscopy performed according to ESGE guidelines. 4. Subjects willing and able to complete the entire study and to comply with instructions. Exclusion Criteria: 1. Pregnancy or breast feeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and practice highly effective methods of birth control throughout the study period, according to the CTCG "Recommendations related to contraception and pregnancy testing in clinical trials" v 1.2\* (unless postmenopausal or surgically sterile, or whose sole sexual partner had a successful vasectomy). 2. Severe acute and chronically active inflammatory bowel disease; subjects in clinical remission (Crohn's Disease Activity Index - CDAI \< 150 for Crohn Disease (Best et al. 1976) and Partial Mayo Score ≤ 2 for Ulcerative Colitis (Schroeder et al. 1987)) are a