Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy

Phase 2 Completed 162 enrolled Paion UK Ltd. Premier Research · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.

Timeline

Start: 2010-05
Primary completion: 2010-09
Completion: 2010-10

Publications

Results Pambianco DJ, Borkett KM, Riff DS, Winkle PJ, Schwartz HI, Melson TI, Wilhelm-Ogunbiyi K. A phase IIb study comparing the safety and efficacy of remimazolam and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):984-92. doi: 10.1016/j.gie.2015.08.062. Epub 2015 Sep 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Midazolam	Small molecule	1 mg	Intravenous
Subject	Remimazolam	Small molecule	2 mg	Intravenous
Subject	Remimazolam	Small molecule	3 mg	Intravenous

Indications

No indication recorded.