LONDON, UK I October 20, 2014 I Norgine B.V. today announced that the Phase II study of its novel, low volume bowel preparation, NER1006, presented at the 79th Annual Scientific Meeting of the American College of Gastroenterology (ACG), Philadelphia, PA, has met its primary efficacy end point of stool weight and co-primary endpoint of cleansing success. The study demonstrated high quality bowel cleansing efficacy with NER1006 vs. MOVIPREP® in screening colonoscopy patients.[1]
The Phase II open-label, randomised study (OPT, n=240) investigated the pharmacodynamics (stool weight), clinical efficacy and tolerability of dose and taste-optimised low-volume PEG-based formulations (NER1006), after split dosing, compared with MOVIPREP®.[1] Results demonstrate that NER1006 achieved high quality bowel cleansing in screening colonoscopy patients, comparable with MOVIPREP®. Cleansing success rates were 90-100%.[1] Stool output was consistently higher with NER1006, and safety and tolerability profiles between treatments were comparable.[1] In addition, most subjects in the NER1006 arms reached clear effluent.[1]
“Effective bowel cleansing is vital to delivering a successful colonoscopy procedure. This Phase II study confirms that NER1006, a low volume preparation, is preferential for some patients and improves tolerability. We are hoping that the Phase III programme will further show the efficacy and tolerability of NER1006,” commented Donna McVey, Chief Development Officer, Norgine.
Norgine has now enrolled the first patient into the first study of its Phase III programme, NOCT, a US study. The Phase III programme consists of three clinical trials: NOCT is a multicentre, randomised, parallel-group clinical trial that is expected to enrol 540 patients across two arms, MORA and DAYB are European studies to further investigate the bowel cleansing efficacy, compliance, safety, patient acceptability and tolerability of NER1006.
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References
1. Halphen M, et al. Pharmacodynamic and clinical evaluation of low-volume polyethylene glycol based bowel cleansing solutions (NER1006) using split dosing in healthy and screening colonoscopy subjects. ACG 2014 abstract #P330
SOURCE: Norgine
Post Views: 28
LONDON, UK I October 20, 2014 I Norgine B.V. today announced that the Phase II study of its novel, low volume bowel preparation, NER1006, presented at the 79th Annual Scientific Meeting of the American College of Gastroenterology (ACG), Philadelphia, PA, has met its primary efficacy end point of stool weight and co-primary endpoint of cleansing success. The study demonstrated high quality bowel cleansing efficacy with NER1006 vs. MOVIPREP® in screening colonoscopy patients.[1]
The Phase II open-label, randomised study (OPT, n=240) investigated the pharmacodynamics (stool weight), clinical efficacy and tolerability of dose and taste-optimised low-volume PEG-based formulations (NER1006), after split dosing, compared with MOVIPREP®.[1] Results demonstrate that NER1006 achieved high quality bowel cleansing in screening colonoscopy patients, comparable with MOVIPREP®. Cleansing success rates were 90-100%.[1] Stool output was consistently higher with NER1006, and safety and tolerability profiles between treatments were comparable.[1] In addition, most subjects in the NER1006 arms reached clear effluent.[1]
“Effective bowel cleansing is vital to delivering a successful colonoscopy procedure. This Phase II study confirms that NER1006, a low volume preparation, is preferential for some patients and improves tolerability. We are hoping that the Phase III programme will further show the efficacy and tolerability of NER1006,” commented Donna McVey, Chief Development Officer, Norgine.
Norgine has now enrolled the first patient into the first study of its Phase III programme, NOCT, a US study. The Phase III programme consists of three clinical trials: NOCT is a multicentre, randomised, parallel-group clinical trial that is expected to enrol 540 patients across two arms, MORA and DAYB are European studies to further investigate the bowel cleansing efficacy, compliance, safety, patient acceptability and tolerability of NER1006.
——————————————–
References
1. Halphen M, et al. Pharmacodynamic and clinical evaluation of low-volume polyethylene glycol based bowel cleansing solutions (NER1006) using split dosing in healthy and screening colonoscopy subjects. ACG 2014 abstract #P330
SOURCE: Norgine
Post Views: 28
