Open Study to Assess the Tolerability, Safety and Efficacy of an Adapted 2 Litre Gut Cleansing Solution (NRL0706) in Routine Colon Cleansing Prior to Colonoscopies for Colon Tumour Screening.
- The subject's written informed consent must be obtained prior to inclusion.
- Male or female ambulatory subjects aged between 40 to 75 years undergoing a complete
colonoscopy for colon cancer screening.
- No history of significant gastrointestinal diseases, including gastrointestinal
obstruction and perforation or acute symptoms requiring a colonoscopy procedure.
- Willing to undergo a colonoscopy for colon cancer screening.
- Willing, able and competent to complete the entire procedure and to comply with study
- Females of childbearing potential must employ an adequate method of contraception.
- History of gastric emptying disorders
- History of ileus, toxic megacolon, gastrointestinal obstruction and colonic
- History of Phenylketonuria
- Known Glucose-6-phosphate dehydrogenase deficiency
- Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/ sodium
- History of colonic resection
- Requirement for permanent medication and associated stable serum concentrations (e.g.
- Presence of congestive heart failure (NYHA III + IV)
- Acute life-threatening cardiovascular disease
- Documented history of severe renal insufficiency
- Application of any unlicensed medication within the previous 3 months or
participation in any other research study in the last 3 months
- Females who are pregnant, nursing or planning a pregnancy. Females of child bearing
potential not using reliable methods of contraception
- Subjects who the investigator feels would not be compliant with the requirements of