BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Summary

To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.

Timeline

Start

2009-02

Primary completion

2009-05

Completion

—

Outcome

Met primary endpoint

paper Successful bowel preparation was more frequent with OSS than with SF-ELS (98.4% vs 89.6%; P = .04). PMID 20646695 ↗

registry Polyethylene Glycol 3350 Based Bowel Preparation vs BLI800; p = 0.038; Difference in success rates 8.8 (95% CI 0.9 to 16.8) NCT00856843 ↗

Publications

• Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010 Aug;72(2):328-36. doi: 10.1016/j.gie.2010.03.1054. Epub 2010 Jun 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BLI800	Unknown	12 unknown	Oral
Comparator	Polyethylene Glycol 3350	Other / unclassified	4 unknown	Oral

Indications

No indication recorded.