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

Sponsor

Ono Pharmaceutical Co. Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT00219375

Collaborator

(none)

649

Enrollment

Locations

Arms

72.1

Patients Per Site

Study Details

Study Description

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 to the study with conventional treatment without sivelestat.

Condition or Disease	Intervention/Treatment	Phase
Acute Lung Injury Systemic Inflammatory Response Syndrome	Drug: Sivelestat sodium hydrate Drug: Sivelestat sodium hydrate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

649 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: E1 This arm is conducted as a separate study (12-601-0001)	Drug: Sivelestat sodium hydrate 0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
Experimental: E2 This arm is conducted as a separate study (12-603-0001).	Drug: Sivelestat sodium hydrate 0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
No Intervention: conventional therapy This arm is conducted as a separate study (12-602-0001)

Arm

Intervention/Treatment

Experimental: E1

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

Drug: Sivelestat sodium hydrate

0.2 mg/kg/hr continuous i.v. infusion - up to 14 days

Experimental: E2

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

Drug: Sivelestat sodium hydrate

0.2 mg/kg/hr continuous i.v. infusion - up to 14 days

No Intervention: conventional therapy

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

Outcome Measures

Primary Outcome Measures

Ventilator free days (VFD) [28 days]

Secondary Outcome Measures

28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

	Site	City	Country
1	Chubu Region Facility	Chubu	Japan
2	Chugoku Region Facility	Chugoku	Japan
3	Hokkaido Region Facility	Hokkaido	Japan
4	Hokuriku Regional Facility	Hokuriku	Japan
5	Kanto Regional Facility	Kanto	Japan
6	Kinki Region Facility	Kinki	Japan
7	Kyushu Region Facility	Kyushu	Japan
8	Shikoku Region Facility	Shikoku	Japan
9	Tohoku Region Facility	Tohoku	Japan