NER 1006 meets primary endpoint in phase III trial for bowel cleaning- Norgine
Norgine announced positive top line results for its phase III study, NOCT, a multicentre, randomised, parallel-group clinical trial comparing the bowel cleansing efficacy of a two-day split-dosing regimen of NER 1006, versus a split-dosing regimen of a trisulfate bowel cleansing solution (SUPREP) in adult patients undergoing screening, surveillance or diagnostic colonoscopy. The NOCT study also assessed the compliance, safety, patient acceptability and tolerability of NER 1006. The NOCT study, which enrolled 621 patients, met both of its primary endpoints. The NOCT study is part of Norgine's NER1006 Phase III clinical trials programme. The programme includes two additional multicentre, randomised, parallel-group clinical trials, MORA and DAYB, that are expected to report in 2015. Full evaluation of the data is ongoing. Complete results from the NOCT study will be submitted to a scientific meeting in 2016.