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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Sivelestat

Treatment: Drugs: Sivelestat
Intervention code [1] 0 0
Treatment: Drugs
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/Phase 2
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
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- 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
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United States of America
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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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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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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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Brussels
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Gent
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Liege
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Alberta
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British Columbia
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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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Canterbury
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Auckland
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Hastings
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Wellington
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Barcelona
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Madrid
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Murcia
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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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00036062
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00036062