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

Phase 4

Completed

• Conditions: Systemic Inflammatory Response Syndrome; Acute Lung Injury
• Interventions: Drug: Sivelestat sodium hydrate

• Registration Number: NCT00219375
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2007-07
• Status Verified: 2012-06
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 649

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E1	Sivelestat sodium hydrate	This arm is conducted as a separate study (12-601-0001)
E2	Sivelestat sodium hydrate	This arm is conducted as a separate study (12-603-0001).

Primary Outcome Measures

Name	Time	Method
Ventilator free days (VFD)	28 days

Secondary Outcome Measures

Name	Time	Method
28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores	28 days

Trial Locations

Locations (9)

Kyushu Region Facility; 🇯🇵 Kyushu, Japan

Tohoku Region Facility; 🇯🇵 Tohoku, Japan

Kinki Region Facility; 🇯🇵 Kinki, Japan

Hokkaido Region Facility; 🇯🇵 Hokkaido, Japan

Kanto Regional Facility; 🇯🇵 Kanto, Japan

Chubu Region Facility; 🇯🇵 Chubu, Japan

Hokuriku Regional Facility; 🇯🇵 Hokuriku, Japan

Chugoku Region Facility; 🇯🇵 Chugoku, Japan

Shikoku Region Facility; 🇯🇵 Shikoku, Japan