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

This study has been completed.

First Received: May 7, 2002 Last Updated: July 18, 2006 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

Drug Information available for: Ono 5046

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Estimated Enrollment:	600
Study Start Date:	August 2001
Estimated Study Completion Date:	December 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036062

Show 110 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided

Study ID Numbers:	6025, H6W-MC-MCAA
Study First Received:	May 7, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00036062 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Sivelestat
acute lung injury

Additional relevant MeSH terms:

ONO 5046
Serine Proteinase Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Respiratory Distress Syndrome, Adult
Respiration Disorders
Enzyme Inhibitors

Pharmacologic Actions
Protease Inhibitors
Pathologic Processes
Respiratory Tract Diseases
Syndrome
Lung Diseases

ClinicalTrials.gov processed this record on November 27, 2009