Conditions: Colorectal Cancer Colorectal Carcinoma Colon Cleansing
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 515
Healthy volunteers: no

Brief summary:
This study evaluates the efficacy, safety and tolerability of NER1006 versus a sodium picosulfate and magnesium salt solution (SP + MS) in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a Day Before Only Dosing regimen. Approximately 484 patients will be randomised with the aim of achieving a minimum of 220 patients in each of the 2 groups.

Detailed description:

Arms:
arm 1: NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy). arm 2: SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).

Interventions: intervention 1: NER1006, Day Before-Only Dosing intervention 2: SP+MS, Day Before-Only Dosing
Intervention descriptions: intervention 1: The subject will self-administer both doses of NER1006 in the evening of Day 1 with 1-2 hours interval. Subject will take mandatory additional clear fluid after each dose. intervention 2: The subject will self-administer SP+MS in the morning of Day 1 and afternoon of Day 1. Subject will take mandatory additional clear fluid after each dose.

Protocol document: