Skip to main content
OpenTrials
Completed

NCT Number: NCT00036062

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Diseases Lung Injury Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Garran, Australian Capital Territory, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sivelestat

Drug

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Important dates

Study start
2001
Study completion
2002
First posted
May 8, 2002
Registry last updated
Jul 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.