A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy

Phase 3 Completed 446 enrolled Paion UK Ltd. Premier Research · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open label arm for midazolam, in patients undergoing a bronchoscopy.

Timeline

Start: 2015-04
Primary completion: 2017-03
Completion: 2017-03-13

Outcome

Met primary endpoint

registry analysis (superiority test); Remimazolam vs Placebo; p <0.0001; Difference in Rates 0.7588 (95% CI 0.6903 to 0.8274) NCT02296892 ↗

Publications

Results Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Midazolam	Small molecule	0.5 mg	Intravenous
Comparator	Midazolam	Small molecule	1 mg	Intravenous
Subject	Remimazolam	Small molecule	2.5 mg	Intravenous

Indications

No indication recorded.