Status:
COMPLETED
Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Acute Lung Injury
Systemic Inflammatory Response Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 t...
Eligibility Criteria
Inclusion
- Patients with systemic inflammatory response syndrome (SIRS)
- Patients with acute lung injury (ALI) assessed using the criteria specified by the American-European Consensus Conference
- Within 72 hours of onset of lung injury
- Other inclusion criteria as specified in the protocol
Exclusion
- Already administrated Sivelestat before enrollment in the study
- Neuromuscular disease that impairs spontaneous ventilation
- Severe central nervous system disease
- Bone marrow transplant
- Lung transplant
- Severe chronic liver disease
- Neutropenia (neutrophil count: below 1000/mm3)
- Other exclusion criteria as specified in the protocol
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
649 Patients enrolled
Trial Details
Trial ID
NCT00219375
Start Date
June 1 2004
Last Update
April 23 2015
Active Locations (9)
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1
Chugoku Region Facility
Chugoku, Japan
2
Chubu Region Facility
Chūbu, Japan
3
Hokkaido Region Facility
Hokkaido, Japan
4
Hokuriku Regional Facility
Hokuriku, Japan