A Phase 3 study comparing the bowel cleansing of NER1006 vs MOVIPREP
Research type
Research Study
Full title
A Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 (a Low Volume Bowel Cleansing Solution) versus MOVIPREP® using a 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimens in Adults
IRAS ID
160850
Contact name
Jonathan Manning
Contact email
Sponsor organisation
Norgine Ltd
Eudract number
2014-002185-78
Research summary
The procedure of colonoscopy (to look at the lining of the large bowel) has gained a growing importance with respect to the diagnosis and prevention of colorectal cancer. In order to perform colonoscopy effectively, it is necessary to empty the contents of the colon and cleanse the bowel.
In order to effectively empty the colon and cleanse the bowel for diagnostic procedures, the passage of approximately 3 litres of watery diarrhoea is required. This can be achieved using laxatives and enemas but many of these are becoming associated with potentially hazardous dehydration (excessive loss of body water) and electrolyte (minerals in your body that have an electric charge) disturbances.
The purpose of this study is to evaluate safety and efficacy of NER1006 (study drug) in a larger population of patients undergoing colonoscopy, whereby as in normal clinical practice for bowel preparation, the patients will be responsible for preparing the study products by themselves for administration. NER1006 will be administered in a 2- day evening/morning split-dosing regimen and in a 1-day morning on day of colonoscopy regimen.
The proposed study is a parallel group (compares two treatments one of which is standard treatment). Participants who provide written consent and meet eligibility criteria will be randomised in a 1:1:1 ratio, 2-Day Split-dosing NER1006: 2-Day Split-dosing MOVIPREP®: 1-Day Morning Split-dosing NER1006
The study includes:
Screening - Confirm if participants are suitable and randomised.
Treatment & procedures (day1 &2) – participants will receive assigned treatment and have colonoscopy performed
Follow up - Participants return for visits on days 3 &4 (visit 4 may be performed as a telephone call)Study procedures include colonoscopy, medical history evaluation, electrocardiogram (ECG; measures heart electrical activity, height, weight, temperature, blood and urine samples, questionnaires, vital signs, adverse event and concomitant (ongoing) medications collection.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
14/WM/1106
Date of REC Opinion
4 Sep 2014
REC opinion
Favourable Opinion