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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00036062
First received: May 7, 2002
Last updated: July 18, 2006
Last verified: July 2006
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


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

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

Keywords provided by Eli Lilly and Company:
Sivelestat
acute lung injury

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
ONO 5046
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014