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

Colorectal Cancer Clinical Trial

Official title: A Clinical Investigation to Demonstrate the Performance of NER1008 Enema in Bowel Cleansing Compared to Fleet® Enema

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer

• NCT number: NCT02468726
• Study type: Interventional
• Source: Norgine
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Completion date: December 2012