A Phase 3 study comparing the bowel cleansing of NER1006 vs (SP+MS)
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 a Sodium Picosulfate and Magnesium Salt (SP+MS) Solution Using a Day Before-Only Dosing Regimen in Adults
IRAS ID
160849
Contact name
Stephen Lewis
Contact email
Sponsor organisation
Norgine Ltd
Eudract number
2014-002186-30
Research summary
Colonoscopy, is an established procedure for the diagnosis of colonic polyps and colorectal cancer. In order to perform colonoscopy effectively, it is necessary to empty the contents of the colon to ensure adequate visulisation.
To achieve effective cleansing, the passage of approximately 3 litres of watery diarrhoea is required. This can be achieved using laxatives and enemas but these are associated with potentially hazardous dehydration (excessive loss of body water) and electrolyte (salts in your body that are important to its normal function) 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 1-daysplit-dosing regimen commencing in the early evening on the day prior to colonoscopy.
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 ratio of NER1006: SP+MS (marketed sodium picosulfate and magnesium salt (administered as a 1-day split dose commencing in the morning of the day prior to colonoscopy)).
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/1108
Date of REC Opinion
4 Sep 2014
REC opinion
Favourable Opinion