A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
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.
Respiratory Distress Syndrome, Adult
Acute Lung Injury
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036062
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