Norgine Presents Phase III Study Design for NER1006, its Low-volume Bowel Cleansing Solution, at United European Gastroenterology Week 2015
LONDON, October 27, 2015 /PRNewswire/ --
Today, at United European Gastroenterology Week 2015, Norgine B.V. presented three ongoing multicentre randomised parallel group phase III studies in 1914 patients undergoing colonoscopy investigating NER1006. The studies are NOCT, MORA and DAYB.[1]
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The NOCT study compares NER1006 versus a trisulfate bowel cleansing solution (SUPREP®) using a 2-day split-dosing regimen in adults. The MORA study compares NER1006 versus MOVIPREP® using a 2-day split-doing regimen and a 1-day morning split-dosing regimen in adults. The DAYB study compares NER1006 versus a sodium picosulfate and magnesium salt solution (CITRAFLEET®) using a day before only dosing regimen in adults.
The findings from these pivotal phase III studies may provide a better understanding of what is required in an optimal bowel preparation, as the quality of bowel preparation is an important factor for a successful colonoscopy.
Peter Martin, Norgine's Chief Operating Officer, said: "Norgine is pleased to be presenting the NER1006 phase III study programme at UEG Week 2015. The development of NER1006 further demonstrates Norgine's commitment to improving outcomes for patients with colon cancer."
Topline results for NOCT were recently announced; complete results from the study will be submitted to a scientific meeting in 2016. MORA and DAYB are expected to report in 2015. NER1006 is not approved for use.
See full release on http://www.norgine.com
References
1. New Low-Volume Bowel Cleansing Solution (NER1006) vs Trisulphate, Polyethylene Glycol 3350+Ascorbate or Sodium Picosulphate/Magnesium Salt: Three Ongoing Multicentre Randomised Parallel Group Phase III Studies in 1914 Patients Undergoing Colonoscopy. Abstract: 15-ABS-3387
Media Contacts:
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Charlotte Andrews, T: +44(0)1895-453607
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SOURCE Norgine B.V.
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