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

Ono Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Systemic Inflammatory Response Syndrome; Acute Lung Injury

Treatments: Drug: Sivelestat sodium hydrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00219375

12-601/602/603-0001

Details and patient eligibility

About

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.

Enrollment: 649 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with systemic inflammatory response syndrome (SIRS)
2. Patients with acute lung injury (ALI) assessed using the criteria specified by the American-European Consensus Conference
3. Within 72 hours of onset of lung injury
4. Other inclusion criteria as specified in the protocol

Exclusion criteria

1. Already administrated Sivelestat before enrollment in the study
2. Neuromuscular disease that impairs spontaneous ventilation
3. Severe central nervous system disease
4. Bone marrow transplant
5. Lung transplant
6. Severe chronic liver disease
7. Neutropenia (neutrophil count: below 1000/mm3)
8. Other exclusion criteria as specified in the protocol

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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649 participants in 3 patient groups

E1

Experimental group

Description:

This arm is conducted as a separate study (12-601-0001)

Treatment:

Drug: Sivelestat sodium hydrate

Drug: Sivelestat sodium hydrate

E2

Experimental group

Description:

This arm is conducted as a separate study (12-603-0001).

Treatment:

Drug: Sivelestat sodium hydrate

Drug: Sivelestat sodium hydrate

conventional therapy

No Intervention group

Description:

This arm is conducted as a separate study (12-602-0001)