drugset / Trial / NCT01533090

Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy

NCT01533090

RandomizedParallel-groupSingle-blindDiagnostic

Summary

The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the procedure is safe and effective. It has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been shown to provide adequate colon cleansing and better tolerability. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.

Timeline

Start
2010-04
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bisacodyl Small molecule 2 unknown
Subject Bisacodyl Small molecule 3 unknown
Comparator polyethylene glycol Other / unclassified 2000 ml
Comparator polyethylene glycol Other / unclassified 4000 ml