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Performance of NER1008 Enema Compared With Fleet® Enema in Bowel Cleansing

NCT02468726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-06-11

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

NER1008 enema

NER1008 enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy

DRUG

Fleet

Fleet enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy

Sponsors & Collaborators

Principal Investigators

  • David J Bell, MD · BioKinetic Europe Ltd

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-12-31

Countries

  • United Kingdom

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02468726 on ClinicalTrials.gov