Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

Phase 3 Completed 500 enrolled Braintree Laboratories

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.

Timeline

Start: 2020-07-13
Primary completion: 2021-01-07
Completion: 2021-02-05

Outcome

Met primary endpoint

paper A high rate of cleansing success was seen with FPSS (94%), which was noninferior to OSS (94%). PMID 37490604 ↗

Publications

Bhandari R, Goldstein M, Mishkin DS, McGowan J, Cleveland MV, Di Palma JA. Comparison of a Novel, Flavor-optimized, Polyethylene Glycol and Sulfate Bowel Preparation With Oral Sulfate Solution in Adults Undergoing Colonoscopy. J Clin Gastroenterol. 2023 Oct 1;57(9):920-927. doi: 10.1097/MCG.0000000000001894.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BLI4900	Unknown	2000 ml	Oral

Indications

No indication recorded.