臨床研究等提出・公開システム

Date of registration	Sept. 12, 2005
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080220086

Scientific Title	Post marketing study of sivelestat sodium hydrate for acute lung injury associated with systemic inflammatory response syndrome
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Ono Pharmaceutical Co., Ltd.
	Address	06-6263-5670
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Open study
Study Design	Objective
Phase		4
Key inclusion & exclusion criteria	Inclusion Criteria	Male and female patients with ALI associated with SIRS aged over 18 years old are included.
	Exclusion Criteria
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Acute lung injury (ALI) associated with systemic inflammatory response syndrome (SIRS)
Intervention(s)		investigational material(s) Generic name etc : Sivelestat sodium hydrate INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy and safety
Secondary Outcome

Primary Sponsor	ONO PHARMACEUTICAL CO.,LTD.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-050088
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Dec. 28, 2015	Detail	Changes
7	Dec. 28, 2015	Detail	Changes
6	June. 25, 2010	Detail	Changes
5	June. 25, 2010	Detail	Changes
4	June. 18, 2008	Detail	Changes
3	June. 18, 2008	Detail	Changes
2	Sept. 12, 2005	Detail	Changes
1	Sept. 12, 2005	Detail

List of change history