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Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan

NCT00219375 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 649

Last updated 2015-04-23

No results posted yet for this study

Summary

The purpose of this study is to confirm the efficacy and safety of sivelestat in patients with acute lung injury associated with systemic inflammatory response syndrome. The results will be compared to the study with conventional treatment without sivelestat.

Conditions

  • Acute Lung Injury
  • Systemic Inflammatory Response Syndrome

Interventions

DRUG

Sivelestat sodium hydrate

0.2 mg/kg/hr continuous i.v. infusion - up to 14 days

DRUG

Sivelestat sodium hydrate

0.2 mg/kg/hr continuous i.v. infusion - up to 14 days

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Project Leader, Development Planning · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2007-07-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00219375 on ClinicalTrials.gov