Date: 2014-11-13
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Norgine Pharma (The Netherlands)
Product: NER1006
Action
mechanism: NER1006 is a novel, low volume polyethylene glycol based bowel preparation that has been developed to provide whole bowel cleansing, with an additional focus on the ascending colon. The dosing regimen of NER1006 (32 fl oz, of bowel preparation solution with 32 fl oz of extra water or clear fluid) aims to deliver a high level of efficacy. This low volume solution should not only support improved patient acceptability and compliance but also to contribute to effectiveness of colonoscopy procedures at detecting colon cancer and for optimised bowel surveillance, through effective bowel cleansing.
Disease: patients undergoing screening, surveillance or diagnostic colonoscopy recruitment of the first patient
Therapeutic area: Gastrointestinal diseases - Digestive diseases
Country: Belgium, Germany, USA
Trial
details: The MORA and DAYB studies are part of Norgine’s NER1006 Phase III clinical trials programme. Both MORA and DAYB are European*** multicentre, randomised, parallel-group clinical trials that are expected to enrol approximately 1,294 patients in total. The Phase III programme also includes a clinical study in the United States, NOCT, which will compare NER1006 versus a trisulfate bowel cleansing solution (SUPREP®) using a 2-day split-dosing regimen in adults. Enrolment for the NOCT trial commenced in September 2014. It is expected to enrol 540 patients across two arms.(NCT02273141, NCT02273167, NCT02254486)
Latest
news: * On November 13, 2014, Norgine announced the enrolment of the first patients into two European Phase III studies (MORA and DAYB) for its investigational product NER1006. The MORA study will evaluate the bowel cleansing efficacy* of NER1006 versus MOVIPREP® using a 2-day split-dosing regimen and a 1-day morning split-dosing regimen in adults. The DAYB study will also evaluate the efficacy* of NER1006 versus a sodium picosulfate and magnesium salt solution (CITRAFLEET®) using a day before only dosing regimen in adults. The MORA and DAYB studies will also assess the compliance, safety, patient acceptability and tolerability of NER1006. * On October 3, 2014, Norgine announced the enrolment of the first patient into the US Phase III study, NOCT, for NER1006. This study will evaluate 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 adult patients undergoing screening, surveillance or diagnostic colonoscopy. The NOCT study will also assess the compliance, safety, patient acceptability and tolerability of NER1006. The NOCT study is part of Norgine\'s NER1006 Phase III clinical trials programme. The Phase III programme also includes two clinical studies in Europe further investigating the bowel cleansing efficacy, compliance, safety, patient acceptability and tolerability of NER1006. The MORA study will compare NER1006 versus MOVIPREP® using a 2-day split-doing regimen and a 1-day morning split-dosing regimen in adults. The DAYB study will compare NER1006 versus a sodium picosulfate and magnesium salt solution (CITRAFLEET®) using a day before only dosing regimen in adults. Enrolment for trials MORA and DAYB are planned to start in late 2014.
