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NCT00219375 Clinical Trial

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

Acute Lung Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00219375
Other study ID # 12-601/602/603-0001
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated April 21, 2015
Start date June 2004

Study information
Verified date June 2012
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 649
Est. completion date
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Sivelestat sodium hydrate
0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
• Sivelestat sodium hydrate
0.2 mg/kg/hr continuous i.v. infusion - up to 14 days

Locations
Country Name City State
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

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ventilator free days (VFD) 28 days No
Secondary 28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores 28 days No
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