NCT00219375

Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan

Efficacy and Safety of Sivelestat Sodium Hydrate in Acute Lung Injury Associated With Systemic Inflammatory Response Syndrome, Compared With the Conventional Treatment in Japan

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 649 (actual)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm the efficacy and safety of sivelestat in patients with acute lung injury associated with systemic inflammatory response syndrome. The results will be compared to the study with conventional treatment without sivelestat.

Conditions

• Acute Lung Injury
• Systemic Inflammatory Response Syndrome

Interventions

Type	Name	Description
DRUG	Sivelestat sodium hydrate	0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
DRUG	Sivelestat sodium hydrate	0.2 mg/kg/hr continuous i.v. infusion - up to 14 days

Timeline

• Start date: 2004-06-01
• Primary completion: 2007-07-01
• First posted: 2005-09-22
• Last updated: 2015-04-23

Locations

9 sites across 1 country: Japan