NCT00219375

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
649

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

April 23, 2015

Status Verified

June 1, 2012

Enrollment Period

3.1 years

First QC Date

September 13, 2005

Last Update Submit

April 21, 2015

Conditions

Acute Lung InjurySystemic Inflammatory Response Syndrome

Keywords

sivelestat sodium hydrateacute lung injurysystemic inflammatory response syndromeElaspolAcute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS)

Outcome Measures

Primary Outcomes (1)

  • Ventilator free days (VFD)

    28 days

Secondary Outcomes (1)

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

    28 days

Study Arms (3)

E1

EXPERIMENTAL

This arm is conducted as a separate study (12-601-0001)

Drug: Sivelestat sodium hydrate

E2

EXPERIMENTAL

This arm is conducted as a separate study (12-603-0001).

Drug: Sivelestat sodium hydrate

conventional therapy

NO INTERVENTION

This arm is conducted as a separate study (12-602-0001)

Interventions

Sivelestat sodium hydrateDRUG

0.2 mg/kg/hr continuous i.v. infusion - up to 14 days

E1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Chugoku Region Facility

Chugoku, Japan

Location

Chubu Region Facility

Chūbu, Japan

Location

Hokkaido Region Facility

Hokkaido, Japan

Location

Hokuriku Regional Facility

Hokuriku, Japan

Location

Kanto Regional Facility

Kanto, Japan

Location

Kinki Region Facility

Kinki, Japan

Location

Kyushu Region Facility

Kyushu, Japan

Location

Shikoku Region Facility

Shikoku, Japan

Location

Tohoku Region Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Acute Lung InjurySystemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Project Leader, Development Planning

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

June 1, 2004

Primary Completion

July 1, 2007

Last Updated

April 23, 2015

Record last verified: 2012-06

Locations

JP(9)