Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan
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| ClinicalTrials.gov Identifier: NCT00219375 |
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Recruitment Status
:
Completed
First Posted
: September 22, 2005
Last Update Posted
: April 23, 2015
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Sponsor:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
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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 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
Genetic and Rare Diseases Information Center resources:
Acute Respiratory Distress Syndrome
Respiratory Distress Syndrome, Infant
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Experimental: E1
This arm is conducted as a separate study (12-601-0001)
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Drug: Sivelestat sodium hydrate
0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
|
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Experimental: E2
This arm is conducted as a separate study (12-603-0001).
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Drug: Sivelestat sodium hydrate
0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
|
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No Intervention: conventional therapy
This arm is conducted as a separate study (12-602-0001)
|
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 ]
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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:
- 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
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 |
| 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:
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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:
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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 |