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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00036062




Registration number
NCT00036062
Ethics application status
Date submitted
7/05/2002
Date registered
8/05/2002
Date last updated
19/07/2006

Titles & IDs
Public title
A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
Scientific title
A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
Secondary ID [1] 0 0
H6W-MC-MCAA
Secondary ID [2] 0 0
6025
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Distress Syndrome, Adult 0 0
Acute Lung Injury 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Inclusion Criteria

* show evidence of acute lung injury
* be on mechanical ventilation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* have undergone certain organ transplants
* have severe underlying medical problems
* be unlikely to survive
* be pregnant or breast-feeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Kingswood
Recruitment hospital [4] 0 0
- Kogarah
Recruitment hospital [5] 0 0
- St. Leonards
Recruitment hospital [6] 0 0
- Wentworthville
Recruitment hospital [7] 0 0
- SouthPort
Recruitment hospital [8] 0 0
- Adelaide
Recruitment hospital [9] 0 0
- Bedford Park
Recruitment hospital [10] 0 0
- Woodville
Recruitment hospital [11] 0 0
- Heidelberg
Recruitment hospital [12] 0 0
- Parkville
Recruitment hospital [13] 0 0
- Prahran
Recruitment hospital [14] 0 0
- Fremantle
Recruitment hospital [15] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Kingswood
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- St. Leonards
Recruitment postcode(s) [6] 0 0
- Wentworthville
Recruitment postcode(s) [7] 0 0
- SouthPort
Recruitment postcode(s) [8] 0 0
- Adelaide
Recruitment postcode(s) [9] 0 0
- Bedford Park
Recruitment postcode(s) [10] 0 0
- Woodville
Recruitment postcode(s) [11] 0 0
- Heidelberg
Recruitment postcode(s) [12] 0 0
- Parkville
Recruitment postcode(s) [13] 0 0
- Prahran
Recruitment postcode(s) [14] 0 0
- Fremantle
Recruitment postcode(s) [15] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Missouri
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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South Dakota
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Tennessee
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Texas
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Virginia
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West Virginia
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Belgium
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Aaist
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Belgium
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Antwerpen
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Belgium
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Arion
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Belgium
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Braine L' Alleud
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Belgium
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Brugge
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Liege
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Alberta
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British Columbia
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Canada
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Manitoba
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Nova Scotia
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Ontario
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Quebec
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New Zealand
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Canterbury
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New Zealand
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Auckland
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Hastings
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New Zealand
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Wellington
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Barcelona
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Madrid
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Murcia
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Spain
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Badajoz
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Spain
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Palma De Mallorca

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00036062