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

April 21, 2015 updated by: Ono Pharmaceutical Co. Ltd

Efficacy and Safety of Sivelestat Sodium Hydrate in Acute Lung Injury Associated With Systemic Inflammatory Response Syndrome, Compared With the Conventional Treatment in Japan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

649

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E1
This arm is conducted as a separate study (12-601-0001)
Drug: Sivelestat sodium hydrate
0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
Experimental: E2
This arm is conducted as a separate study (12-603-0001).
Drug: Sivelestat sodium hydrate
0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
No Intervention: conventional therapy
This arm is conducted as a separate study (12-602-0001)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ventilator free days (VFD)
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Project Leader, Development Planning, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-601/602/603-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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