Performance of NER1008 Enema Compared With Fleet® Enema in Bowel Cleansing
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
In order for flexible sigmoidoscopy to be a successful screening procedure, the bowel must be
free of solid matter so the endoscopist has a clear view, increasing the chance of detection
of abnormalities. This is achieved through the use of bowel cleansing preparations, which are
administered prior to the procedure. Enemas are the preferred method as they clear the lower
bowel more quickly than oral formulations and do not require dietary restrictions.
The medical device being tested in this clinical investigation is NER1008, an enema which
contains PEG3350 (polyethylene glycol 3350). PEG3350 is an osmotic agent, which holds the
water content in the rectum and sigmoid colon, consequently increasing stool volume,
resulting in rectal distension and subsequent distal colon emptying. The increased colonic
luminal content stimulates the motility, propulsive transportation and rectal evacuation of
the distal colon content.
This study is designed to assess the performance of NER1008 in bowel cleansing and compare
this with the performance of Fleet® enema, which is widely used for this purpose.