Agio-Prep 3g versus Agio-Prep 6g versus Moviprep® - a prospective, randomised, controlled evaluation of bowel cleansing for colonoscopy

INTERVENTION: Trade Name: Moviprep Product Name: Moviprep Pharmaceutical Form: Powder for oral solution CAS Number: 0 Other descriptive name: MACROGOL 3350 Concentration unit: g gram(s) Concentration type: equal Concentration number: 200‐ CAS Number: 7681381 Other descriptive name: SODIUM SULFATE Concentration unit: g gram(s) Concentration type: equal Concentration number: 15‐ CAS Number: 7647‐14‐5 Other descriptive name: SODIUM CHLORIDE Concentration unit: g gram(s) Concentration type: equal Concentration number: 5.382‐ CAS Number: 7447‐40‐7 Other descriptive name: POTASSIUM CHLORIDE Concentration unit: g gram(s) Concentration type: equal Concentration number: 2.03‐ Other descriptive name: Ascorbic acid Concentration unit: g gram(s) Concentration type: equal Concentration number: 4.700‐ INN or Proposed INN: SODIUM ASCORBATE CAS Number: 134‐03‐2 Concentration unit: g gram(s) Concentration type: equal Concentration number: 5.900‐ Product Name: Agiolax‐Micro Product Code: Agiolax‐Micro Pharmaceutical Form: Granules Other descriptive name: Plantago ovata seeds powdered Concentration unit: g gram(s) Concentration type: equal Concentration number: 2.1‐ Other descriptive name: Dry extract Tin. Senna Pods, (4‐6):1, 15mg Hydroxyanthracene‐Glyc., calc. Sennoside B, Extr. Water Concentration unit: mg milligram(s) Concentration type: range Concentration number: 127.5‐172.5 Product Name: Macrogol‐Plus Product Code: Macrogol‐Plus Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Polyethylene Glycol 3550 Other descriptive name: Macrogol 3350 Concentration unit: g gram(s) Concentration type: equal Concentration number: 210‐ INN or Proposed INN: Sodium chloride Concentration unit: g gram(s) Concentration type: equal Concentration number: 5.6‐ INN or Proposed INN: Sodium bicarbonate Concentration unit: g gram(s) Concentration type: equal Concentration number: 2.86‐ INN or Proposed INN: Potassium chloride Concentration unit: g gram(s) Concentration type: equal Concentration CONDITION: Bowel Preparation for Colonoscopy INCLUSION CRITERIA: Gender: male/female Age: =18 years Scheduled for colonoscopy Subjects eligible for colorectal cancer screening Good state of health (no clinically significant deviations from normal clinical results and laboratory test findings) The subject must give written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range PRIMARY OUTCOME: Main Objective: To assess the efficacy of Test products compared with Reference product for bowel cleansing as rated by the Boston bowel preparation scale (BBPS) Primary end point(s): Mean of BBPS score Secondary Objective: To assess subjective acceptance of taking the bowel preparation treatment for Test products in comparison with Reference product (VAS); To assess frequency of incomplete bowel preparation for Test products in comparison with Reference product; To assess frequency of abdominal symptoms due to bowel preparation treatment for Test products in comparison with Reference product; To assess frequency of incomplete colonoscopies with insufficient view due to low diagnostic quality at the first attempt for Test products in comparison with Reference product; To assess characterisation of safety and tolerability of the investigational products considering Adverse Events, rate of nausea and emesis, blood electrolytes and vital signs in the study population for Test products in comparison with Reference product;