A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
2 other identifiers
interventional
600
6 countries
110
Brief Summary
The purpose of this study is to determine whether sivelestat will reduce the amount of time a patient must spend on a ventilator and/or increase the chance of survival of patients with acute lung injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2001
110 active sites
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
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 7, 2002
CompletedFirst Posted
Study publicly available on registry
May 8, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2002
CompletedJuly 19, 2006
July 1, 2006
May 7, 2002
July 18, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- show evidence of acute lung injury
- be on mechanical ventilation
You may not qualify if:
- have undergone certain organ transplants
- have severe underlying medical problems
- be unlikely to survive
- be pregnant or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (110)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Orange, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Englewood, Colorado, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Bay Pines, Florida, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Austell, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Elk Grove Village, Illinois, United States
Unknown Facility
Maywood, Illinois, United States
Unknown Facility
North Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Des Moines, Iowa, United States
Unknown Facility
Kansas City, Kansas, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Baton Rouge, Louisiana, United States
Unknown Facility
Lake Charles, Louisiana, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Portland, Maine, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Silver Spring, Maryland, United States
Unknown Facility
Towson, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Camden, New Jersey, United States
Unknown Facility
Hackensack, New Jersey, United States
Unknown Facility
Holmdel, New Jersey, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
Elmhurst, New York, United States
Unknown Facility
Manhasset, New York, United States
Unknown Facility
Mineola, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
Greensboro, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Akron, Ohio, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Allentown, Pennsylvania, United States
Unknown Facility
Hershey, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Providence, Rhode Island, United States
Unknown Facility
Sioux Falls, South Dakota, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Irving, Texas, United States
Unknown Facility
Lubbock, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Newport News, Virginia, United States
Unknown Facility
Morgantown, West Virginia, United States
Unknown Facility
Garran, Australian Capital Territory, Australia
Unknown Facility
Camperdown, New South Wales, Australia
Unknown Facility
Kingswood, New South Wales, Australia
Unknown Facility
Kogarah, New South Wales, Australia
Unknown Facility
St Leonards, New South Wales, Australia
Unknown Facility
Wentworthville, New South Wales, Australia
Unknown Facility
Southport, Queensland, Australia
Unknown Facility
Adelaide, South Australia, Australia
Unknown Facility
Bedford Park, South Australia, Australia
Unknown Facility
Woodville, South Australia, Australia
Unknown Facility
Heidelberg, Victoria, Australia
Unknown Facility
Parkville, Victoria, Australia
Unknown Facility
Prahran, Victoria, Australia
Unknown Facility
Fremantle, Western Australia, Australia
Unknown Facility
Perth, Western Australia, Australia
Unknown Facility
Aaist, Belgium
Unknown Facility
Antwerp, Belgium
Unknown Facility
Arion, Belgium
Unknown Facility
Braine-l'Alleud, Belgium
Unknown Facility
Bruges, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Liège, Belgium
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Winnipeg, Manitoba, Canada
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
Hamilton, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Windsor, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Sherbrooke, Quebec, Canada
Unknown Facility
Christchurch, Canterbury, New Zealand
Unknown Facility
Auckland, New Zealand
Unknown Facility
Hastings, New Zealand
Unknown Facility
Wellington, New Zealand
Unknown Facility
Badajoz, Badajoz, Spain
Unknown Facility
Manresa, Barcelona, Spain
Unknown Facility
Sabadell, Barcelona, Spain
Unknown Facility
Getafe, Madrid, Spain
Unknown Facility
Madrid, Madrid, Spain
Unknown Facility
El Palmar, Murcia, Spain
Unknown Facility
Murcia, Murcia, Spain
Unknown Facility
Palma de Mallorca, Palma de Mallorca, Spain
Unknown Facility
Barcelona, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 7, 2002
First Posted
May 8, 2002
Study Start
August 1, 2001
Study Completion
December 1, 2002
Last Updated
July 19, 2006
Record last verified: 2006-07