Who is sponsoring NCT00219375?

NCT00219375 is sponsored by Ono Pharmaceutical Co., Ltd..

What drugs are being tested in NCT00219375?

Interventions in NCT00219375: Sivelestat sodium hydrate, Sivelestat sodium hydrate.

What condition does NCT00219375 study?

NCT00219375 studies Acute Lung Injury, Systemic Inflammatory Response Syndrome.

Is NCT00219375 still recruiting?

NCT00219375 is currently completed. Last updated 21 April 2015.

Last reviewed 2015-04-21 · How we verify

NCT00219375

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of Sivelestat Sodium Hydrate in Acute Lung Injury Associated With Systemic Inflammatory Response Syndrome, Compared With the Conventional Treatment in Japan

Completed Phase 4 Last updated 21 April 2015

What this trial tests

Phase 4 trial testing Sivelestat sodium hydrate in Acute Lung Injury in 649 participants. Completed.

Timeline

1 June 2004

Primary endpoint
1 July 2007

Quick facts

Lead sponsor	Ono Pharmaceutical Co., Ltd.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	649
Start date	1 June 2004
Primary completion	1 July 2007
Sites	9 locations across Japan

Drugs / interventions tested

Sivelestat sodium hydrate — full drug profile →
Sivelestat sodium hydrate — full drug profile →

Conditions studied

Acute Lung Injury — all drugs for Acute Lung Injury →
Systemic Inflammatory Response Syndrome — all drugs for Systemic Inflammatory Response Syndrome →

Sponsor

Ono Pharmaceutical Co., Ltd.

Who can join

18 and older, any sex, with Acute Lung Injury or Systemic Inflammatory Response Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Ventilator free days (VFD)
Time frame: 28 days

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Acute Respiratory Distress Syndrome and COVID-19: A Literature Review.
Hussain M, Khurram Syed S, Fatima M, Shaukat S, et al · · 2021 · cited 38× · PMID 34992415 · DOI 10.2147/jir.s334043
Exploring neutrophil extracellular traps: mechanisms of immune regulation and future therapeutic potential.
Gao F, Peng H, Gou R, Zhou Y, et al · · 2025 · cited 18× · PMID 40442839 · DOI 10.1186/s40164-025-00670-3
What every intensivist should know about acute respiratory distress syndrome and diffuse alveolar damage.
Rios F, Iscar T, Cardinal-Fernández P. · · 2017 · cited 17× · PMID 28977098 · DOI 10.5935/0103-507x.20170044

Verify or expand the search:

Other recruiting trials for Acute Lung Injury

Currently open trials in the same condition.

NCT05704166 — PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients · Phase 2 · recruiting

Other Ono Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07169708 — A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable · not yet recruiting
NCT06936943 — ONO-4538 Study in Patients With Richter's Transformation · Phase 2 · recruiting
NCT06948448 — A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 an · Phase 2 · recruiting
NCT07198087 — A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impa · Phase 1 · active not recruiting
NCT06803823 — A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00219375 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ono Pharmaceutical Co., Ltd.
Last refreshed: 21 April 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00219375.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing