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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00036062

Enrollment

600

Registered

2002-05-08

Start date

2001-08-31

Completion date

2002-12-31

Last updated

2006-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Adult, Acute Lung Injury

Keywords

Sivelestat, acute lung injury

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.

Interventions

DRUGSivelestat

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

Australia, Belgium, Canada, New Zealand, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026