Conditions: Colorectal Cancer Colorectal Carcinoma Colon Cleansing
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 849
Healthy volunteers: no

Brief summary:
This study evaluates the efficacy, safety and tolerability of NER1006 versus MOVIPREP in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day evening/morning Split-Dosing and 1-Day morning only Split-Dosing regimens. Approximately 810 patients will be randomised with the aim of achieving a minimum of 245 patients in each of the 3 groups.

Detailed description:

Arms:
arm 1: NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy). arm 2: NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy). arm 3: MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).

Interventions: intervention 1: NER1006, 2-Day Split-Dosing intervention 2: NER1006,1-Day Morning Split-Dosing intervention 3: MOVIPREP, 2-Day Split-Dosing
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 investigational product on the morning of the colonoscopy and take mandatory additional clear fluid.

After a 1-2 hour break the subject will self-administer the second dose plus additional clear mandatory fluid. intervention 3: The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take recommended additional clear fluid. Subject will take the second dose together with recommended additional clear fluids on the morning of the colonoscopy.

Protocol document: