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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219375
First Posted: September 22, 2005
Last Update Posted: April 23, 2015
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.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
  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
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

Resource links provided by NLM:


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

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

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
First Submitted: September 13, 2005
First Posted: September 22, 2005
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:
Syndrome
Wounds and Injuries
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