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

Primary Purpose

Acute Lung Injury, Systemic Inflammatory Response Syndrome

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Sivelestat sodium hydrate
Sivelestat sodium hydrate
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring sivelestat sodium hydrate, acute lung injury, systemic inflammatory response syndrome, Elaspol, Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chubu Region Facility
  • Chugoku Region Facility
  • Hokkaido Region Facility
  • Hokuriku Regional Facility
  • Kanto Regional Facility
  • Kinki Region Facility
  • Kyushu Region Facility
  • Shikoku Region Facility
  • Tohoku Region Facility

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

E1

E2

conventional therapy

Arm Description

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)

Outcomes

Primary Outcome Measures

Ventilator free days (VFD)

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
April 21, 2015
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00219375
Brief Title
Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Systemic Inflammatory Response Syndrome
Keywords
sivelestat sodium hydrate, acute lung injury, systemic inflammatory response syndrome, Elaspol, Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
649 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E1
Arm Type
Experimental
Arm Description
This arm is conducted as a separate study (12-601-0001)
Arm Title
E2
Arm Type
Experimental
Arm Description
This arm is conducted as a separate study (12-603-0001).
Arm Title
conventional therapy
Arm Type
No Intervention
Arm Description
This arm is conducted as a separate study (12-602-0001)
Intervention Type
Drug
Intervention Name(s)
Sivelestat sodium hydrate
Intervention Description
0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
Intervention Type
Drug
Intervention Name(s)
Sivelestat sodium hydrate
Intervention Description
0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
Primary Outcome Measure Information:
Title
Ventilator free days (VFD)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Project Leader, Development Planning
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Chubu Region Facility
City
Chubu
Country
Japan
Facility Name
Chugoku Region Facility
City
Chugoku
Country
Japan
Facility Name
Hokkaido Region Facility
City
Hokkaido
Country
Japan
Facility Name
Hokuriku Regional Facility
City
Hokuriku
Country
Japan
Facility Name
Kanto Regional Facility
City
Kanto
Country
Japan
Facility Name
Kinki Region Facility
City
Kinki
Country
Japan
Facility Name
Kyushu Region Facility
City
Kyushu
Country
Japan
Facility Name
Shikoku Region Facility
City
Shikoku
Country
Japan
Facility Name
Tohoku Region Facility
City
Tohoku
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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