Performance of NER1008 Enema Compared With Fleet® Enema in Bowel Cleansing
|ClinicalTrials.gov Identifier: NCT02468726|
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : June 11, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Device: NER1008 enema Drug: Fleet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Clinical Investigation to Demonstrate the Performance of NER1008 Enema in Bowel Cleansing Compared to Fleet® Enema|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||December 2012|
Use of NER1008 enema for bowel cleansing
Device: NER1008 enema
NER1008 enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy
Active Comparator: Fleet
Use of Fleet enema for bowel cleansing
Fleet enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy
- Success of bowel cleansing [ Time Frame: Up to 3 hours ]Whether recto-sigmoid bowel cleansing has been successful, based on an endoscopist's assessment of the quality of cleansing in the rectum and colon, according to the modified Harefield cleansing scale.
- Grade of bowel cleansing [ Time Frame: Up to 3 hours ]Grade of bowel cleansing (A, B, C or D), based on an endoscopist's assessment.
- Quality of cleansing in rectum [ Time Frame: Up to 3 hours ]Quality of cleansing in the rectum based on the modified Harefield cleansing scale (0-4).
- Quality of cleansing in sigmoid colon [ Time Frame: Up to 3 hours ]Quality of cleansing in the sigmoid colon based on the modified Harefield cleansing scale (0-4)
- Quality of cleansing in the descending colon [ Time Frame: Up to 3 hours ]Quality of cleansing in the descending colon to the splenic flexure based on the modified Harefield cleansing scale (0-4)
- Depth of scope progression [ Time Frame: Up to 3 hours ]Prior to removing the endoscope, the depth of progression it has made, in cms
- Stool weight [ Time Frame: Up to 3 hours ]Weight of stool during the one hour period after the administration of the enema
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468726
|BioKinetic Europe Ltd|
|Belfast, United Kingdom, BT2 7BA|
|Principal Investigator:||David J Bell, MD||BioKinetic Europe Ltd|