Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy

Phase 2 Completed 100 enrolled Paion UK Ltd. Premier Research · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.

Timeline

Start: 2009-03
Primary completion: 2009-09
Completion: 2009-09

Publications

Results Borkett KM, Riff DS, Schwartz HI, Winkle PJ, Pambianco DJ, Lees JP, Wilhelm-Ogunbiyi K. A Phase IIa, randomized, double-blind study of remimazolam (CNS 7056) versus midazolam for sedation in upper gastrointestinal endoscopy. Anesth Analg. 2015 Apr;120(4):771-80. doi: 10.1213/ANE.0000000000000548.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midazolam	Small molecule	0.075 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.1 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.15 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.2 mg/kg	Intravenous

Indications

No indication recorded.