A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury

NCT ID: NCT00036062

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2002-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Respiratory Distress Syndrome, Adult Acute Lung Injury

Keywords

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Sivelestat acute lung injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sivelestat

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* show evidence of acute lung injury
* be on mechanical ventilation

Exclusion Criteria

* have undergone certain organ transplants
* have severe underlying medical problems
* be unlikely to survive
* be pregnant or breast-feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Portland, Maine, United States

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Baltimore, Maryland, United States

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Silver Spring, Maryland, United States

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Towson, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Kalamazoo, Michigan, United States

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St Louis, Missouri, United States

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Camden, New Jersey, United States

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Hackensack, New Jersey, United States

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Holmdel, New Jersey, United States

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Buffalo, New York, United States

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Elmhurst, New York, United States

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Manhasset, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Bay Pines, Florida, United States

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Clearwater, Florida, United States

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Fort Lauderdale, Florida, United States

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Augusta, Georgia, United States

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Austell, Georgia, United States

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Chicago, Illinois, United States

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Elk Grove Village, Illinois, United States

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Maywood, Illinois, United States

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North Chicago, Illinois, United States

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Orange, California, United States

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Sacramento, California, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Greensboro, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Toledo, Ohio, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Sioux Falls, South Dakota, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Lubbock, Texas, United States

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San Antonio, Texas, United States

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Newport News, Virginia, United States

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Morgantown, West Virginia, United States

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Garran, Australian Capital Territory, Australia

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Camperdown, New South Wales, Australia

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Kingswood, New South Wales, Australia

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Kogarah, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Wentworthville, New South Wales, Australia

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Southport, Queensland, Australia

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Adelaide, South Australia, Australia

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Bedford Park, South Australia, Australia

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Woodville, South Australia, Australia

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Heidelberg, Victoria, Australia

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Parkville, Victoria, Australia

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Prahran, Victoria, Australia

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Fremantle, Western Australia, Australia

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Perth, Western Australia, Australia

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Aaist, , Belgium

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Antwerp, , Belgium

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Arion, , Belgium

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Braine-l'Alleud, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Liège, , Belgium

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Christchurch, Canterbury, New Zealand

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Auckland, , New Zealand

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Hastings, , New Zealand

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Wellington, , New Zealand

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Badajoz, Badajoz, Spain

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Manresa, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Getafe, Madrid, Spain

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Madrid, Madrid, Spain

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El Palmar, Murcia, Spain

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Murcia, Murcia, Spain

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Palma de Mallorca, Palma de Mallorca, Spain

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Barcelona, , Spain

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Countries

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United States Australia Belgium Canada New Zealand Spain

Other Identifiers

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H6W-MC-MCAA

Identifier Type: -

Identifier Source: secondary_id

6025

Identifier Type: -

Identifier Source: org_study_id