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Efficacy of novel low-volume bowel prep demonstrated in phase 3 trial
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NER1006, a novel, low-volume polyethylene glycol-based bowel preparation, was shown to be effective for bowel cleansing in patients undergoing colonoscopy in a phase 3 clinical trial, the manufacturer announced.
“These positive top-line results demonstrate the potential of NER1006 [Norgine] as a novel bowel cleansing agent to deliver an effective colonoscopy,” Peter Martin, Norgine’s COO, said in a press release. “These data are encouraging as a major milestone on the development of this novel bowel cleansing agent.”
In this phase 3, multicenter, randomized, parallel-group clinical trial (NOCT study), researchers randomly assigned 621 adults undergoing screening, surveillance or diagnostic colonoscopy, to receive either a 2-day split-dose regimen of NER1006 or a split-dose regimen of SUPREP (Braintree Laboratories), a trisulfate bowel cleansing solution, according to the press release. Bowel cleansing efficacy, compliance, safety, patient acceptability and tolerability were evaluated. Both of the study’s primary endpoints were met, but assessment of other data is ongoing, with complete results to be submitted to a 2016 scientific meeting.
The NOCT study is part of the NER1006 phase 3 clinical trials program, which includes two additional trials whose results are expected in 2015. NER1006 is not currently approved for use.
Disclosures: Martin reports he is an employee of Norgine.