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

Phase 1

Completed

• Conditions: Respiratory Distress Syndrome, Adult; Acute Lung Injury

• Registration Number: NCT00036062
• Lead Sponsor: Eli Lilly and Company

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 Timeline

• Study Start: 2001-08
• Study First Submitted: 2002-05-07
• Study First Submitted QC: 2002-05-07
• Study First Posted: 2002-05-08
• Study Completion: 2002-12
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-18
• Last Update Posted: 2006-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL