Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00219375
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : June 2004
Actual Primary Completion Date : July 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Ventilator free days (VFD) [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. 28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores [ Time Frame: 28 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219375


Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. Ltd
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00219375     History of Changes
Other Study ID Numbers: 12-601/602/603-0001
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: June 2012
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:
Layout table for MeSH terms
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Syndrome
Systemic Inflammatory Response Syndrome
Wounds and Injuries
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