Conditions: Colon Cancer Colorectal Carcinoma Colon Cleansing
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 621
Healthy volunteers: no

Brief summary:
This study evaluates the efficacy, safety and tolerability of NER1006 versus Trisulfate Solution (TS) in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day evening/morning Split-Dosing regimen. Approximately 540 patients will be randomised with the aim of achieving a minimum of 245 patients in each of the 2 groups.

Detailed description:

Arms:
arm 1: NER1006:2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy) arm 2: Trisulfate Solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)

Interventions: intervention 1: NER1006 intervention 2: Trisulfate solution
Intervention descriptions: intervention 1: The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy. intervention 2: The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.

Protocol document: