Efficacy and Safety of Sivelestat Sodium Hydrate in Acute Lung Injury Associated With Systemic Inflammatory Response Syndrome, Compared With the Conventional Treatment in Japan
Sponsor study identifier
interventional
649
1 country
9
Study Start
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2007
Actual (reported)Study Completion
Not reported
Date not reportedThe 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 22, 2005
Actual (reported)July 2007
Actual (reported)Ventilator free days (VFD)
28 days
28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores
28 days
This arm is conducted as a separate study (12-601-0001)
This arm is conducted as a separate study (12-603-0001).
This arm is conducted as a separate study (12-602-0001)
0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chugoku Region Facility
Chugoku, Japan
Chubu Region Facility
Chūbu, 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
Project Leader, Development Planning
Ono Pharmaceutical Co., Ltd.
649 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
Evaluation of Corticosteroid in Systemic Inflammatory Response Syndrome
Contact the study team to confirm eligibility.
Shikoku Region Facility
Shikoku, Japan
Tohoku Region Facility
Tōhoku, Japan
Primary Completion
July 2007
Actual (reported)Last Updated
April 23, 2015
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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