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| Sponsor: | Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00036062 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Distress Syndrome, Adult Acute Lung Injury |
Drug: Sivelestat |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury |
| Estimated Enrollment: | 600 |
| Study Start Date: | August 2001 |
| Estimated Study Completion Date: | December 2002 |
Acute lung injury often develops as a result of severe infection, sepsis, severe injuries, inhalation of foreign substances into the lungs, or pneumonia. The tissues and blood vessels in the lungs become inflamed, and the body does not receive enough oxygen. Patients with this condition are placed on a ventilator to assist with breathing.
Patients entered into this study will be randomly assigned to one of two treatment groups: a sivelestat group or a placebo group. Once entered into the study, patients are monitored for up to 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Phoenix, Arizona, United States | |
| Tucson, Arizona, United States | |
| United States, California | |
| Sacramento, California, United States | |
| Orange, California, United States | |
| San Diego, California, United States | |
| United States, Colorado | |
| Englewood, Colorado, United States | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| New Haven, Connecticut, United States | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Bay Pines, Florida, United States | |
| Clearwater, Florida, United States | |
| Ft. Lauderdale, Florida, United States | |
| United States, Georgia | |
| Austell, Georgia, United States | |
| Augusta, Georgia, United States | |
| United States, Illinois | |
| Elk Grove Village, Illinois, United States | |
| Maywood, Illinois, United States | |
| North Chicago, Illinois, United States | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| Indianapolis, Indiana, United States | |
| United States, Iowa | |
| Des Moines, Iowa, United States | |
| United States, Kansas | |
| Kansas City, Kansas, United States | |
| United States, Kentucky | |
| Louisville, Kentucky, United States | |
| Lexington, Kentucky, United States | |
| United States, Louisiana | |
| Lake Charles, Louisiana, United States | |
| Shreveport, Louisiana, United States | |
| Baton Rouge, Louisiana, United States | |
| United States, Maine | |
| Portland, Maine, United States | |
| United States, Maryland | |
| Towson, Maryland, United States | |
| Baltimore, Maryland, United States | |
| Silver Spring, Maryland, United States | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| Detroit, Michigan, United States | |
| Kalamazoo, Michigan, United States | |
| United States, Missouri | |
| St. Louis, Missouri, United States | |
| United States, New Jersey | |
| Camden, New Jersey, United States | |
| Holmdel, New Jersey, United States | |
| Hackensack, New Jersey, United States | |
| United States, New York | |
| Mineola, New York, United States | |
| Rochester, New York, United States | |
| New York, New York, United States | |
| Bronx, New York, United States | |
| Buffalo, New York, United States | |
| Manhasset, New York, United States | |
| Elmhurst, New York, United States | |
| United States, North Carolina | |
| Greensboro, North Carolina, United States | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| Akron, Ohio, United States | |
| Toledo, Ohio, United States | |
| Cincinnati, Ohio, United States | |
| United States, Oregon | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Allentown, Pennsylvania, United States | |
| Pittsburgh, Pennsylvania, United States | |
| Philadelphia, Pennsylvania, United States | |
| Hershey, Pennsylvania, United States | |
| United States, Rhode Island | |
| Providence, Rhode Island, United States | |
| United States, South Dakota | |
| Sioux Falls, South Dakota, United States | |
| United States, Tennessee | |
| Nashville, Tennessee, United States | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| Lubbock, Texas, United States | |
| Houston, Texas, United States | |
| San Antonio, Texas, United States | |
| Irving, Texas, United States | |
| United States, Virginia | |
| Newport News, Virginia, United States | |
| United States, West Virginia | |
| Morgantown, West Virginia, United States | |
| Australia, Australian Capital Territory | |
| Garran, Australian Capital Territory, Australia | |
| Australia, New South Wales | |
| Camperdown, New South Wales, Australia | |
| Kogarah, New South Wales, Australia | |
| St. Leonards, New South Wales, Australia | |
| Wentworthville, New South Wales, Australia | |
| Kingswood, New South Wales, Australia | |
| Australia, Queensland | |
| SouthPort, Queensland, Australia | |
| Australia, South Australia | |
| Bedford Park, South Australia, Australia | |
| Adelaide, South Australia, Australia | |
| Woodville, South Australia, Australia | |
| Australia, Victoria | |
| Parkville, Victoria, Australia | |
| Prahran, Victoria, Australia | |
| Heidelberg, Victoria, Australia | |
| Australia, Western Australia | |
| Perth, Western Australia, Australia | |
| Fremantle, Western Australia, Australia | |
| Belgium | |
| Brugge, Belgium | |
| Liege, Belgium | |
| Brussels, Belgium | |
| Arion, Belgium | |
| Aaist, Belgium | |
| Gent, Belgium | |
| Braine L' Alleud, Belgium | |
| Antwerpen, Belgium | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Hamilton, Ontario, Canada | |
| Toronto, Ontario, Canada | |
| Windsor, Ontario, Canada | |
| Canada, Quebec | |
| Montreal, Quebec, Canada | |
| Sherbrooke, Quebec, Canada | |
| New Zealand | |
| Auckland, New Zealand | |
| Wellington, New Zealand | |
| Hastings, New Zealand | |
| New Zealand, Canterbury | |
| Christchurch, Canterbury, New Zealand | |
| Spain | |
| Madrid, Spain | |
| Badajoz, Spain | |
| Barcelona, Spain | |
| Murcia, Spain | |
| Palma De Mallorca, Spain | |
| Spain, Barcelona | |
| Sabadell, Barcelona, Spain | |
| Manresa, Barcelona, Spain | |
| Spain, Madrid | |
| Getafe, Madrid, Spain | |
| Spain, Murcia | |
| El Palmar, Murcia, Spain | |
More Information
| Study ID Numbers: | 6025, H6W-MC-MCAA |
| Study First Received: | May 7, 2002 |
| Last Updated: | July 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00036062 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Sivelestat acute lung injury |
|
ONO 5046 Serine Proteinase Inhibitors Disease Molecular Mechanisms of Pharmacological Action Respiratory Distress Syndrome, Adult Respiration Disorders Enzyme Inhibitors |
Pharmacologic Actions Protease Inhibitors Pathologic Processes Respiratory Tract Diseases Syndrome Lung Diseases |
