Respiratory Distress Syndrome, AdultPhase 1/2NCT00036062
A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
A Phase 1/2 study testing Sivelestat in people with Respiratory Distress Syndrome, Adult and Acute Lung Injury, run by Eli Lilly and Company at 110 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Acute Lung Injury
- What is being tested?
- Sivelestat
- How many people
- 600 participants
- Where
- 110 sitesin 6 countries
- Study dates
- Aug 2001to Dec 2002
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- show evidence of acute lung injury
- be on mechanical ventilation
Who cannot join
- have undergone certain organ transplants
- have severe underlying medical problems
- be unlikely to survive
- be pregnant or breast-feeding
Trial locations and contacts
110 sites in 6 countries.
110 sites in 6 countries
United States65 sites
Study site
Akron, Ohio
Study site
Allentown, Pennsylvania
Study site
Augusta, Georgia
Study site
Austell, Georgia
Study site
Baltimore, Maryland
Study site
Baton Rouge, Louisiana
Study site
Bay Pines, Florida
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Buffalo, New York
Study site
Camden, New Jersey
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Denver, Colorado
Study site
Des Moines, Iowa
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Detroit, Michigan
Study site
Elk Grove Village, Illinois
Study site
Elmhurst, New York
Study site
Englewood, Colorado
Study site
Fort Lauderdale, Florida
Study site
Greensboro, North Carolina
Study site
Hackensack, New Jersey
Study site
Hershey, Pennsylvania
Study site
Holmdel, New Jersey
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Irving, Texas
Study site
Kalamazoo, Michigan
Study site
Kansas City, Kansas
Study site
Lake Charles, Louisiana
Study site
Lexington, Kentucky
Study site
Louisville, Kentucky
Study site
Lubbock, Texas
Study site
Manhasset, New York
Study site
Maywood, Illinois
Study site
Memphis, Tennessee
Study site
Mineola, New York
Study site
Morgantown, West Virginia
Study site
Nashville, Tennessee
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Newport News, Virginia
Study site
North Chicago, Illinois
Study site
Orange, California
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Maine
Study site
Portland, Oregon
Study site
Providence, Rhode Island
Study site
Rochester, New York
Study site
Sacramento, California
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Shreveport, Louisiana
Study site
Silver Spring, Maryland
Study site
Sioux Falls, South Dakota
Study site
St Louis, Missouri
Study site
The Bronx, New York
Study site
Toledo, Ohio
Study site
Towson, Maryland
Study site
Tucson, Arizona
Study site
Washington D.C., District of Columbia
Study site
Winston-Salem, North Carolina
Australia15 sites
Study site
Adelaide, South Australia
Study site
Bedford Park, South Australia
Study site
Camperdown, New South Wales
Study site
Fremantle, Western Australia
Study site
Garran, Australian Capital Territory
Study site
Heidelberg, Victoria
Study site
Kingswood, New South Wales
Study site
Kogarah, New South Wales
Study site
Parkville, Victoria
Study site
Perth, Western Australia
Study site
Prahran, Victoria
Study site
Southport, Queensland
Study site
St Leonards, New South Wales
Study site
Wentworthville, New South Wales
Study site
Woodville, South Australia
Canada9 sites
Study site
Edmonton, Alberta
Study site
Halifax, Nova Scotia
Study site
Hamilton, Ontario
Study site
Montreal, Quebec
Study site
Sherbrooke, Quebec
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Study site
Windsor, Ontario
Study site
Winnipeg, Manitoba
Spain9 sites
Study site
Badajoz, Badajoz
Study site
Barcelona
Study site
El Palmar, Murcia
Study site
Getafe, Madrid
Study site
Madrid, Madrid
Study site
Manresa, Barcelona
Study site
Murcia, Murcia
Study site
Palma de Mallorca, Palma de Mallorca
Study site
Sabadell, Barcelona
Belgium8 sites
Study site
Aaist
Study site
Antwerp
Study site
Arion
Study site
Braine-l'Alleud
Study site
Bruges
Study site
Brussels
Study site
Ghent
Study site
Liège
New Zealand4 sites
Study site
Auckland
Study site
Christchurch, Canterbury
Study site
Hastings
Study site
Wellington
About this study
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.
Read the 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.
- Being tested
- Sivelestat
- Keywords
- Sivelestat, acute lung injury
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SivelestatDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2002 (estimated)
- Study startAug 2001
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036062
- Sponsor's protocol ID
- 6025
- Other IDs
- H6W-MC-MCAA
- Status last verified
- Jul 2006
- First submitted
- 7 May 2002
- Last updated
- 19 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
- ClinicalTrials.gov ID
- NCT00036062
- Acronym / sponsor ID
- 6025
- Keywords
- Sivelestat, acute lung injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Study completion
- Dec 2002
- First posted
- 8 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- show evidence of acute lung injury
- be on mechanical ventilation
Key exclusion criteria (4 listed)
- have undergone certain organ transplants
- have severe underlying medical problems
- be unlikely to survive
- be pregnant or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sivelestat | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
110 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sivelestat in people with Respiratory Distress Syndrome, Adult and Acute Lung Injury, run by Eli Lilly and Company at 110 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States, Australia, Canada, Spain, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2006.