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ONO-5046Na in Acute Respiratory Failure with Pneumonia
NCT00417326Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2006
- Primary completion
- Aug 2009
- Countries
- 1
- Sponsor
- Ono Pharmaceutical
- Modality
- Small Molecules
- Drugs
- sivelestat
- Conditions
- acute respiratory failure (ARF)
01
Overview
Phase 2, randomised, double-blind trial of sivelestat in acute respiratory failure (ARF) (2 arms), sponsored by Ono Pharmaceutical. Primary endpoint: Pulmonary function at 14 days. Started Dec 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo Comparator
Placebo infusion
Experimental
Sivelestat (ONO-5046Na) 0.2 mg/kg/hr infusion
03
Who it enrols
Patients with acute respiratory failure associated with community-acquired pneumonia, excluding those with nosocomial pneumonia or on mechanical ventilation.
04
Endpoints
Primary
Pulmonary function
Secondary
Mortality
Ventilator status
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