A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy

Summary

The objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.

Timeline

Start

2018-01-11

Primary completion

2018-07-10

Completion

2018-07-10

Outcome

Met primary endpoint

paper OST was noninferior to PEG-EA in this study PMID 33165006 ↗

registry analysis (non-inferiority test); BLI4700 Bowel Preparation vs FDA Approved Bowel Preparation; p <0.001 NCT03404401 ↗

Publications

• Di Palma JA, Bhandari R, Cleveland MV, Mishkin DS, Tesoriero J, Hall S, McGowan J. A Safety and Efficacy Comparison of a New Sulfate-Based Tablet Bowel Preparation Versus a PEG and Ascorbate Comparator in Adult Subjects Undergoing Colonoscopy. Am J Gastroenterol. 2021 Feb 1;116(2):319-328. doi: 10.14309/ajg.0000000000001020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BLI4700	Unknown	—	Oral
Comparator	PEG-EA	Unknown	—	Oral

Indications

No indication recorded.