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	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acute Respiratory Distress Syndrome Respiratory Distress Syndrome, Infant

U.S. FDA Resources

Further study details as provided by Ono Pharmaceutical Co. Ltd:

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
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)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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

Sponsors and Collaborators

Ono Pharmaceutical Co. Ltd

Investigators


Study Director:	Project Leader, Development Planning	Ono Pharmaceutical Co. Ltd

More Information


Responsible Party:	Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:	NCT00219375 History of Changes
Other Study ID Numbers:	12-601/602/603-0001
Study First Received:	September 13, 2005
Last Updated:	April 21, 2015
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharmaceutical Co. Ltd:


sivelestat sodium hydrate acute lung injury systemic inflammatory response syndrome Elaspol Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS)

Additional relevant MeSH terms:


Wounds and Injuries Syndrome Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Systemic Inflammatory Response Syndrome Disease Pathologic Processes Lung Diseases Respiratory Tract Diseases Thoracic Injuries Respiration Disorders	Inflammation Shock Sivelestat Glycine Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Glycine Agents Neurotransmitter Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016