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| Sponsored by: |
Eli Lilly and Company |
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00036062 |
Purpose
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 | Intervention | Phase |
|
Respiratory Distress Syndrome, Adult Acute Lung Injury |
Drug: Sivelestat |
Phase I Phase II |
| Drug Information available for: | Ono 5046 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury |
| Estimated Enrollment: | 600 |
| 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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations![]() |
Show 110 Study Locations |
| Eli Lilly and Company |
More Information
| Study ID Numbers: | 6025, H6W-MC-MCAA |
| First Received: | May 7, 2002 |
| Last Updated: | July 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00036062 |
| Health Authority: | United States: Food and Drug Administration |
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