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

Tracking Information
First Received Date ^ICMJE	May 7, 2002
Last Updated Date	July 18, 2006
Start Date ^ICMJE	August 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00036062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
Official Title ^ICMJE	A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
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.
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 Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Respiratory Distress Syndrome, Adult Acute Lung Injury
Intervention ^ICMJE	Drug: Sivelestat
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	600
Completion Date	December 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Belgium, Canada, New Zealand, Spain

Administrative Information
NCT ID ^ICMJE	NCT00036062
Responsible Party
Study ID Numbers ^ICMJE	6025, H6W-MC-MCAA
Study Sponsor ^ICMJE	Eli Lilly and Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP