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

July 18, 2006 updated by: Eli Lilly and Company
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

600

Phase

  • Phase 2
  • Phase 1

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

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia
    • New South Wales
      • Camperdown, New South Wales, Australia
      • Kingswood, New South Wales, Australia
      • Kogarah, New South Wales, Australia
      • St. Leonards, New South Wales, Australia
      • Wentworthville, New South Wales, Australia
    • Queensland
      • SouthPort, Queensland, Australia
    • South Australia
      • Adelaide, South Australia, Australia
      • Bedford Park, South Australia, Australia
      • Woodville, South Australia, Australia
    • Victoria
      • Heidelberg, Victoria, Australia
      • Parkville, Victoria, Australia
      • Prahran, Victoria, Australia
    • Western Australia
      • Fremantle, Western Australia, Australia
      • Perth, Western Australia, Australia
  • Belgium
      • Aaist, Belgium
      • Antwerpen, Belgium
      • Arion, Belgium
      • Braine L' Alleud, Belgium
      • Brugge, Belgium
      • Brussels, Belgium
      • Gent, Belgium
      • Liege, Belgium
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Toronto, Ontario, Canada
      • Windsor, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • New Zealand
      • Auckland, New Zealand
      • Hastings, New Zealand
      • Wellington, New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand
  • Spain
      • Badajoz, Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Murcia, Spain
      • Palma De Mallorca, Spain
    • Barcelona
      • Manresa, Barcelona, Spain
      • Sabadell, Barcelona, Spain
    • Madrid
      • Getafe, Madrid, Spain
    • Murcia
      • El Palmar, Murcia, Spain
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Orange, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
    • Colorado
      • Denver, Colorado, United States
      • Englewood, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Bay Pines, Florida, United States
      • Clearwater, Florida, United States
      • Ft. Lauderdale, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
      • Austell, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Elk Grove Village, Illinois, United States
      • Maywood, Illinois, United States
      • North Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Lake Charles, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maine
      • Portland, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Silver Spring, Maryland, United States
      • Towson, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Kalamazoo, Michigan, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New Jersey
      • Camden, New Jersey, United States
      • Hackensack, New Jersey, United States
      • Holmdel, New Jersey, United States
    • New York
      • Bronx, New York, United States
      • Buffalo, New York, United States
      • Elmhurst, New York, United States
      • Manhasset, New York, United States
      • Mineola, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Greensboro, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Toledo, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Tennessee
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • Irving, Texas, United States
      • Lubbock, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Newport News, Virginia, United States
    • West Virginia
      • Morgantown, West Virginia, United States

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Eli Lilly and Company

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

August 1, 2001

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

May 7, 2002

First Submitted That Met QC Criteria

May 7, 2002

First Posted (Estimate)

May 8, 2002

Study Record Updates

Last Update Posted (Estimate)

July 19, 2006

Last Update Submitted That Met QC Criteria

July 18, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6025
  • H6W-MC-MCAA

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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