A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
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|ClinicalTrials.gov Identifier: NCT00036062|
Recruitment Status : Completed
First Posted : May 8, 2002
Last Update Posted : July 19, 2006
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome, Adult Acute Lung Injury||Drug: Sivelestat||Phase 1 Phase 2|
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 (Clinical Trial)|
|Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Completion Date :||December 2002|
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
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