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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00036062
Recruitment Status : Completed
First Posted : May 8, 2002
Last Update Posted : July 19, 2006
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Acute Lung Injury Drug: Sivelestat Phase 1 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
Study Start Date : August 2001
Estimated Study Completion Date : December 2002


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036062


  Show 110 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
More Information

ClinicalTrials.gov Identifier: NCT00036062     History of Changes
Other Study ID Numbers: 6025
H6W-MC-MCAA
First Posted: May 8, 2002    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006

Keywords provided by Eli Lilly and Company:
Sivelestat
acute lung injury

Additional relevant MeSH terms:
Wounds and Injuries
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Injury
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Sivelestat
Glycine
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glycine Agents
Neurotransmitter Agents
Physiological Effects of Drugs