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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:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00219375
First received: September 13, 2005
Last updated: June 12, 2012
Last verified: June 2012
History of Changes

September 13, 2005
June 12, 2012
June 2004
July 2007   (final data collection date for primary outcome measure)
Ventilator free days (VFD) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Ventilator free days (VFD)
Complete list of historical versions of study NCT00219375 on ClinicalTrials.gov Archive Site
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 ]
28-day period survival rate, weaning rate from mechanical ventilation, ICU discharge rate, lung injury scores
Not Provided
Not Provided
 
Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan
Efficacy and Safety of Sivelestat Sodium Hydrate in Acute Lung Injury Associated With Systemic Inflammatory Response Syndrome, Compared With the Conventional Treatment in Japan

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Lung Injury
  • Systemic Inflammatory Response Syndrome
  • Drug: Sivelestat sodium hydrate
    0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
  • Drug: Sivelestat sodium hydrate
    0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
  • Other: conventional therapy
    conventional therapy without Sivelestat
  • Experimental: E1
    This arm is conducted as a separate study (12-601-0001)
    Intervention: Drug: Sivelestat sodium hydrate
  • Experimental: E2
    This arm is conducted as a separate study (12-603-0001).
    Intervention: Drug: Sivelestat sodium hydrate
  • No Intervention: -
    This arm is conducted as a separate study (12-602-0001)
    Intervention: Other: conventional therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
649
Not Provided
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00219375
12-601/602/603-0001
Not Provided
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
Not Provided
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP