Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation

Phase 3 Completed 162 enrolled Pfizer Maruishi Pharmaceutical · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and the safety of DA-9501 (Dexmedetomidine) in sedation during the surgery or medical procedure without intubation under monitored sedation care.

Timeline

Start: 2011-07
Primary completion: 2012-02
Completion: 2012-03

Publications

Inagaki Y, Morita K, Ozaki M, Matsumoto K, Okayama A, Oya N, Hiraoka T, Takeda J. The Efficacy and Safety of Dexmedetomidine for Procedural Sedation in Patients Receiving Local Anesthesia Outside the Intensive Care Unit: A Prospective, Double-Blind, Randomized Clinical Phase III Trial in Japan. Yonago Acta Med. 2022 Jan 21;65(1):26-43. doi: 10.33160/yam.2022.02.005. eCollection 2022 Feb.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	DA-9501	Unknown	0.5 ug/kg	—
Comparator	DA-9501	Unknown	1 ug/kg	—

Indications

No indication recorded.