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

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

U.S. FDA Resources

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

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

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

Keywords provided by Eli Lilly and Company:

Sivelestat

acute lung injury

Study placed in the following topic categories:

ONO 5046

Respiratory Tract Diseases

Lung Diseases

Respiration Disorders

Respiratory Distress Syndrome, Adult

Acute respiratory distress syndrome

Additional relevant MeSH terms:

Serine Proteinase Inhibitors

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00036062