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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
  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 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:


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: -
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:

  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
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

No publications provided

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: June 12, 2012
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:
Acute Lung Injury
Lung Injury
Respiratory Distress Syndrome, Adult
Syndrome
Systemic Inflammatory Response Syndrome
Disease
Inflammation
Lung Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Shock
Thoracic Injuries
Wounds and Injuries
Glycine
Sivelestat
Enzyme Inhibitors
Glycine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Serine Proteinase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014