NCT01438931

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

Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation Under Monitored Sedation Care

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Hospira, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase III, randomized, placebo controlled, double blind, parallel comparative study (Therapeutic confirmatory trial), to evaluate the efficacy and the safety of Dexmedetomidine in non-intubated patients who require sedation during surgery or medical procedure under monitored sedation care.

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	DA-9501	Dexmedetomidine hydrochloride variable dose
DRUG	placebo

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2011-09-22
• Last updated: 2015-07-24

Locations

18 sites across 1 country: Japan