Clinical Trial on Bowel Preparation Comparing Mannitol 100g to Plenvu Both in a Same Day Regimen (CLEARWAY)

Not provided

Inclusion criteria

• Ability of subject to consent and provide signed written informed consent.
• Age ≥ 18 years.
• Males and females scheduled for elective colonoscopy performed according to ESGE guidelines.
• Subjects willing and able to complete the entire study and to comply with instructions.

Exclusion criteria

• 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).
• 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 allowed.
• Severe renal failure: eGFR < 30 ml/min/1.73 m2 estimated by simplified MDRD equation.
• Severe heart failure: New York Heart Association (NYHA) Class III-IV.
• Severe anaemia (Hb ≤ 8 g/dl).
• Chronic liver disease Child-Pugh class B or C.
• Electrolyte disturbances (baseline values of Na2+, Cl-, K+ out of normal ranges).
• Clinically significant alterations of baseline haemato-chemical parameters.
• Recent (< 6 months) symptomatic acute ischemic heart disease.
• History of significant gastrointestinal surgeries, including colon resection, sub-total colectomy, abdominoperineal resection, de-functioning colostomy or ileostomy, Hartmann's procedure and other surgeries involving the structure and function of the colon.
• History of paralysis of the gut (ileus).
• History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.).
• History of phenylketonuria (due to presence of aspartame).
• History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate).
• History of toxic megacolon.
• Use within 24 hours prior to colonoscopy of laxatives, colon motility altering drugs and/or other substances (e.g., simethicone) that could affect bowel cleansing or visibility during colonoscopy.
• Suspected bowel obstruction or perforation.
• Indication for partial colonoscopy.
• Subjects who received an investigational drug or therapy within 5 half-lives of the first visit.
• Hypersensitivity to the active ingredients or to any of the excipients of the study drugs.
• Underwater colonoscopy instead of standard gas insufflation.