Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep®

Inclusion Criteria

• Ability of patient to consent and provide signed written informed consent
• Age ≥ 18 years
• Males and females scheduled for elective (screening, surveillance or diagnostic) colonoscopy to be prepared and performed according to the European Society of Gastrointestinal Endoscopy (ESGE) Guideline
• Patients willing and able to complete the entire study and to comply with instructions

Exclusion Criteria

• Pregnancy or breastfeeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and must practice one of the following methods of birth control throughout the study period (unless postmenopausal or surgically sterile, or whose sole sexual partner has had a successful vasectomy): oral, implantable, or injectable contraceptives (for a minimum of three months before study entry) in combination with a condom; intrauterine device in combination with a condom; double barrier method (condom and occlusive cap with spermicidal foam/gel/film/cream/suppository).
• Severe renal failure: glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 estimated by means of simplified MDRD equation.
• Severe heart failure: NYHA Class III-IV.
• Severe anaemia (Hb ≤ 8 g/dl).
• Severe acute and chronically active Inflammatory Bowel Disease; patients in clinical remission (Crohn's Disease Activity Index - CDAI < 150 for Crohn Disease and Partial Mayo Score ≤ 2 for Ulcerative Colitis) are allowed.
• Chronic liver disease Child-Pugh class B or C.
• Electrolyte disturbances (Na, Cl, K, Ca or P out of normal ranges).
• 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.
• Use of laxatives, colon motility altering drugs and/or other substances (e.g. simethicone) that can affect bowel cleansing or visibility during colonoscopy within 24 hours prior to colonoscopy.
• Suspected bowel obstruction or perforation.
• Indication for partial colonoscopy.
• Patients who have received an investigational drug or therapy within 5 half-lives of the first visit.
• Patients previously screened for participation in this study.
• Hypersensitivity to the active ingredients or to any of the excipients of the study drugs.
• Contraindication to Moviprep® (only for phase III).