Navigation Links
Positive Results from Phase II Data Show NER1006 Achieves High Quality Bowel Cleansing Efficacy
Date:10/20/2014

LONDON, October 20, 2014 /PRNewswire/ --

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]

(Logo: http://photos.prnewswire.com/prnh/20130829/633895-a)

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 

 

See full release on http://www.norgine.com

Charlotte Andrews: Tel - +44-(0)1895-453669

Peter Martin: Tel- +44-(0)1895-453744

 

Job code: GL/COR/1014/0024

October 2014


'/>"/>
SOURCE Norgine B.V
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Intarcia Announces Two Positive Phase 3 Trials for ITCA 650 in Type 2 Diabetes: FREEDOM-1 and FREEDOM-1 High Baseline (HBL) Study Results
2. Ardelyx Reports Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C Patients
3. Regeneron and Sanofi Announce Positive Phase 2 Top-line Dupilumab Results in Patients with Chronic Sinusitis with Nasal Polyps
4. SALVAT Announces Positive Top-line Results from Two Phase III Studies of its Novel Otic Antibiotic/Steroid Combination Solution in the Treatment of AOMT with Tympanostomy Tubes
5. Meritage Pharma Announces Positive Results of Oral Budesonide Suspension for Treatment of Eosinophilic Esophagitis in Adolescent and Adult Patients
6. Glenmarks TRPA1 Antagonist GRC 17536 Shows Positive Data in a Proof of Concept Study
7. ROX Medical presents positive data for CONTROL-HTN resistant hypertension trial
8. Aratana Therapeutics Reports Positive Effectiveness Data from Pilot Field Study of Bupivacaine Extended-Release Injectable Suspension (AT-003)
9. Blueprint Medicines Presents Positive Data on BLU-554 for Hepatocellular Carcinoma
10. Mast Therapeutics Announces Positive Top Line Results From Phase 2 Study Of AIR001 For Pulmonary Arterial Hypertension And AIR001 Clinical Development Plan
11. Fractyl Labs Announces Positive Clinical Data for First Procedural Therapy to Treat Type 2 Diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2017)... , Sept. 18, 2017 EpiVax, ... of bioinformatics and immune engineering, today announced ... influenza A (H7N9) vaccine. ... to seasonal influenza and presents a challenge ... prior exposure to be effective. Using state-of-the-art ...
(Date:9/12/2017)... 12, 2017   EcoVadis , the leading platform for environmental, social ... annual edition of its Global CSR Risk and Performance Index. The report ... based on Scorecard Ratings that analyzed nearly 800,000 data points across the ... ... ...
(Date:9/12/2017)... 12, 2017  ValGenesis Inc., the global leader ... pleased to announce the appointment of Dr. ... Board of Directors and Chairman of Advisory Board ... science companies to manage their entire validation lifecycle ... in this process. Furthermore, ValGenesis VLMS enables rigorous ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the ... today its plans to open a flagship location in Covington, LA at 401 N. ... To Go store next to Office Depot in the Holiday Square shopping center. Its ...
(Date:10/12/2017)... , ... October 12, 2017 , ... IsoComforter, Inc. ( ... announced today the introduction of an innovative new design of the shoulder pad. ... you get maximum comfort while controlling your pain while using cold therapy. By utilizing ...
(Date:10/12/2017)... ... ... Asante, a nationally recognized health system in southern Oregon, ... health joint venture through an agreement, effective October 1, 2017, to create AccentCare ... company with Asante, delivering clinically integrated care, for the past eight years. This ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... Hair Restoration, has recently contributed a medical article to the newly revamped ... Dr. Mohebi’s article spotlights the hair transplant procedure known as Follicular Unit ...
(Date:10/12/2017)... ... , ... Leading pediatric oncology experts at Children’s National Health System ... of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. Chaired by ... Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., Chief of the ...
Breaking Medicine News(10 mins):