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

Purpose

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	Intervention	Phase
Acute Lung Injury Systemic Inflammatory Response Syndrome	Drug: Sivelestat sodium hydrate Other: conventional therapy	Phase IV

Drug Information available for:

Ono 5046

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Ono Pharma:

Primary Outcome Measures:

Ventilator free days (VFD) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment:	649
Study Start Date:	June 2004
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
E1: Experimental 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
E2: Experimental 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 This arm is conducted as a separate study (12-602-0001)	Other: conventional therapy conventional therapy without Sivelestat

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219375

Locations


Japan
	Tohoku Region Facility
	Tohoku, Japan
	Hokkaido Region Facility
	Hokkaido, Japan
	Chubu Region Facility
	Chubu, Japan
	Kinki Region Facility
	Kinki, Japan
	Hokuriku Regional Facility
	Hokuriku, Japan
	Shikoku Region Facility
	Shikoku, Japan
	Kyushu Region Facility
	Kyushu, Japan
	Kanto Regional Facility
	Kanto, Japan
	Chugoku Region Facility
	Chugoku, Japan

Sponsors and Collaborators

Ono Pharma

Investigators


Study Director:	Project Leader, Development Planning	Ono Pharma

More Information

Responsible Party:	Development Headquarters, Ono Pharmaceutical Co., Ltd. ( Hiroshi Awata, Executive Director )
Study ID Numbers:	12-601/602/603-0001
First Received:	September 13, 2005
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00219375
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharma:

sivelestat sodium hydrate

acute lung injury

systemic inflammatory response syndrome

Elaspol

Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS)

Study placed in the following topic categories:

ONO 5046

Systemic Inflammatory Response Syndrome

Shock

Respiratory Tract Diseases

Lung Diseases

Respiration Disorders

Respiratory Distress Syndrome, Adult

Acute respiratory distress syndrome

Inflammation

Additional relevant MeSH terms:

Serine Proteinase Inhibitors

Pathologic Processes

Disease

Molecular Mechanisms of Pharmacological Action

Syndrome

Enzyme Inhibitors

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00219375