Acute Lung InjuryPhase 4NCT00219375
Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan
A Phase 4 study testing Sivelestat sodium hydrate in people with Acute Lung Injury and Systemic Inflammatory Response Syndrome, run by Ono Pharmaceutical Co., Ltd. at 9 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury, Systemic Inflammatory Response Syndrome
- What is being tested?
- Sivelestat sodium hydrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 649 participants
- Where
- 9 sitesJapan
- Study dates
- Jun 2004to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with systemic inflammatory response syndrome (SIRS)
- Patients with acute lung injury (ALI) assessed using the criteria specified by the American-European Consensus Conference
- Within 72 hours of onset of lung injury
- Other inclusion criteria as specified in the protocol
Who cannot join
- Already administrated Sivelestat before enrollment in the study
- Neuromuscular disease that impairs spontaneous ventilation
- Severe central nervous system disease
- Bone marrow transplant
- Lung transplant
- Severe chronic liver disease
- Neutropenia (neutrophil count: below 1000/mm3)
- Other exclusion criteria as specified in the protocol
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Chubu Region Facility
Chūbu
Chugoku Region Facility
Chugoku
Hokkaido Region Facility
Hokkaido
Hokuriku Regional Facility
Hokuriku
Kanto Regional Facility
Kanto
Kinki Region Facility
Kinki
Kyushu Region Facility
Kyushu
Shikoku Region Facility
Shikoku
Tohoku Region Facility
Tōhoku
About this study
Official title: Efficacy and Safety of Sivelestat Sodium Hydrate in Acute Lung Injury Associated With Systemic Inflammatory Response Syndrome, Compared With the Conventional Treatment in Japan
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.
- Being tested
- Sivelestat sodium hydrate
- Keywords
- sivelestat sodium hydrate, acute lung injury, systemic inflammatory response syndrome, Elaspol, Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS)
- Medical subject headings
- Acute Lung Injury, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sivelestat sodium hydrateDrug
0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
Sivelestat sodium hydrateDrug
0.2 mg/kg/hr continuous i.v. infusion - up to 14 days
| Study group | Role | What they receive |
|---|---|---|
| E1 | Experimental | This arm is conducted as a separate study (12-601-0001) Receives: Drug: Sivelestat sodium hydrate |
| E2 | Experimental | This arm is conducted as a separate study (12-603-0001). Receives: Drug: Sivelestat sodium hydrate |
| conventional therapy | No intervention | This arm is conducted as a separate study (12-602-0001) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days (VFD)
Measured: 28 days
Secondary outcomes (1)
28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Development Planning, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219375
- Sponsor's protocol ID
- 12-601/602/603-0001
- Status last verified
- Jun 2012
- First submitted
- 13 Sep 2005
- Last updated
- 23 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sivelestat Sodium Hydrate in Acute Lung Injury Associated With Systemic Inflammatory Response Syndrome, Compared With the Conventional Treatment in Japan
- ClinicalTrials.gov ID
- NCT00219375
- Acronym / sponsor ID
- 12-601/602/603-0001
- Keywords
- sivelestat sodium hydrate, acute lung injury, systemic inflammatory response syndrome, Elaspol, Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jul 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| E1 | Experimental | Drug: Sivelestat sodium hydrateThis arm is conducted as a separate study (12-601-0001) |
| E2 | Experimental | Drug: Sivelestat sodium hydrateThis arm is conducted as a separate study (12-603-0001). |
| conventional therapy | No intervention | –This arm is conducted as a separate study (12-602-0001) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with systemic inflammatory response syndrome (SIRS)
- Patients with acute lung injury (ALI) assessed using the criteria specified by the American-European Consensus Conference
- Within 72 hours of onset of lung injury
- Other inclusion criteria as specified in the protocol
Key exclusion criteria (8 listed)
- Already administrated Sivelestat before enrollment in the study
- Neuromuscular disease that impairs spontaneous ventilation
- Severe central nervous system disease
- Bone marrow transplant
- Lung transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sivelestat sodium hydrate0.2 mg/kg/hr continuous i.v. infusion - up to 14 days | Drug | E1 |
| Sivelestat sodium hydrate0.2 mg/kg/hr continuous i.v. infusion - up to 14 days | Drug | E2 |
Primary outcome
Ventilator free days (VFD)
Time frame: 28 days
1 secondary outcome
28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader, Development Planning study director
Ono Pharmaceutical Co., Ltd.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sivelestat sodium hydrate in people with Acute Lung Injury and Systemic Inflammatory Response Syndrome, run by Ono Pharmaceutical Co., Ltd. at 9 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator free days (VFD) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015.