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news.Netherlands-based pharmaceutical firm Norgine has enrolled the first patient in its US Phase III trial (NOCT) of its investigational product, NER1006, in adult patients undergoing screening, surveillance or diagnostic colonoscopy.
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NER1006 is a low volume polyethylene glycol based bowel preparation developed to provide whole bowel cleansing, with an additional focus on the ascending colon.
The multicenter, randomized, parallel-group NOCT trial is designed to assess the bowel cleansing efficacy of a two-day split-dosing regimen of NER1006, versus a split-dosing regimen of a trisulfate bowel cleansing solution (SUPREP) in these patients.
Compliance, safety, patient acceptability and tolerability of NER1006 will also be evaluated in this trial.
The dosing regimen of NER1006, 32 fl oz, of bowel preparation solution with 32 fl oz of extra water or clear fluid, aims to provide high level of efficacy.
Around 540 patients across two arms will be enrolled in the NOCT trial, which is part of the company’s NER1006 Phase III clinical trials program that also includes two clinical trials in Europe further investigating the bowel cleansing efficacy, compliance, safety, patient acceptability and tolerability of the drug candidate.
The MORA trial will compare NER1006 versus MOVIPREP using a two-day split-doing regimen and a one-day morning split-dosing regimen in adults, while the DAYB trial will compare NER1006 versus a sodium picosulfate and magnesium salt solution (CITRAFLEET) using a day before only dosing regimen in adults.
The company plans to start patient enrollment in the MORA and DAYB trials in late 2014.