Introduction: A Phase 3 program aims to establish efficacy, safety, tolerability of NER1006, a new oral low-volume polyethylene glycol (PEG) solution with ascorbate (Asc), in a large adult colonoscopy patient population Methods: Three multicenter, randomized, colonoscopist-blinded parallel group studies in males/females (18-85 years) are underway. Main inclusion criteria: screening, surveillance or diagnostic colonoscopy patients. Main exclusion criteria include: history (≤12 months) or current severe constipation episode; known/suspected ileus; gastrointestinal (GI) obstruction; gastric retention; bowel perforation; toxic colitis or megacolon; ongoing severe acute inflammatory bowel disease; previous significant GI surgeries. NOCT (NCT02254486) will randomize (1:1) ≤620 US patients to NER1006 (2-day split dosing starting evening of the day before colonoscopy) or trisulfate solution (per label). MORA (NCT02273167; 2014-002185-78) will randomize (1:1:1) ≤850 European patients to NER1006 (2-day evening/morning splitdosing and 1-day morning on day of colonoscopy) or PEG3350+Asc (per label). DAYB (NCT02273141; 2014-002186-30) will randomize (1:1) ≤530 European patients to NER1006 (1-day, day before-only split dosing starting evening of the day before colonoscopy) or sodium picosulfate/magnesium salt (per label). Study duration: ≤4 clinic visits/patient for ≤40 days. Alternative primary endpoints: 1. NER1006 overall bowel cleansing success rate is non-inferior to comparator using the Harefield Cleansing Scale (HCS); 2. NER1006 ‘Excellent plus Good' cleansing rate in colon ascendens is non-inferior to comparator using HCS segmental cleansing scoring system. Central readers will score colonoscopy videos. Key secondary endpoints include: adenoma and polyp detection rates in colon ascendens and overall. Results: As of May 2015, number of patients randomized were: 610/620 at 12 US sites (NOCT); 507/850 at 30 sites in Belgium, France, Germany, Italy, Poland, Spain and UK (MORA); 369/530 at 20 sites in Germany, Italy, Netherlands, Poland, Spain, and UK (DAYB). Studies are due to complete by September 2015. Conclusion: Quality of bowel preparation is an important factor for a successful colonoscopy but lavage solution volume required to achieve efficacy/tolerability is often a barrier. Findings from these pivotal Phase 3 studies of a new low-volume bowel preparation may provide a better understanding of what is required in an optimal bowel preparation.
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