Community-acquired PneumoniaPhase 2NCT00417326
Controlled Study of ONO-5046Na in Patients With Acute Respiratory Failure Associated With Community-Acquired Pneumonia
A Phase 2 study testing ONO-5046Na in people with Community-acquired Pneumonia, run by Ono Pharmaceutical Co., Ltd. at 9 sites in Japan.
Trial summary
The purpose of this study is to determine the safety and efficacy of ONO-5046Na in patients with acute respiratory failure associated with community-acquired pneumonia Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- ONO-5046Na
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 9 sitesJapan
- Study dates
- Dec 2006to Aug 2009
- Phase
- Phase 2
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with community-acquired pneumonia
- Patients with acute respiratory failure
Who cannot join
- Patients with nosocomial pneumonia
- Patients on mechanical ventilation
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Chubu Region
Chūbu
Chugoku Region
Chugoku
Hokkaido Region
Hokkaido
Hokuriku Region
Hokuriku
Kanto Region
Kanto
Kinki Region
Kinki
Kyushu Region
Kyushu
Shikoku Region
Shikoku
Tohoku Region
Tohuku
About this study
Official title: ONO-5046Na Phase II Study - A Pilot Study for Patients With Acute Respiratory Failure
The purpose of this study is to determine the safety and efficacy of ONO-5046Na in patients with acute respiratory failure associated with community-acquired pneumonia
- Conditions
- Community-acquired Pneumonia
- Being tested
- ONO-5046Na
- Keywords
- ONO-5046Na, acute respiratory failure, community-acquired pneumonia
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-5046NaDrug
twenty four hour infusion at 0 mg/kg/hr for 14 days
ONO-5046NaDrug
twenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days
| Study group | Role | What they receive |
|---|---|---|
| P | Placebo comparator | Not described Receives: Drug: ONO-5046Na |
| E | Experimental | Not described Receives: Drug: ONO-5046Na |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary function
Measured: 14 days
Secondary outcomes (2)
mortality
Measured: 28 days
ventilator status
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 posted1 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Koji Takehara, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417326
- Sponsor's protocol ID
- ONO-5046Na-14
- Status last verified
- Jun 2012
- First submitted
- 28 Dec 2006
- Last updated
- 13 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONO-5046Na Phase II Study - A Pilot Study for Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT00417326
- Acronym / sponsor ID
- ONO-5046Na-14
- Conditions
- Community-acquired Pneumonia
- Keywords
- ONO-5046Na, acute respiratory failure, community-acquired pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2009 (actual)
- First posted
- 1 Jan 2007 (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 determine the safety and efficacy of ONO-5046Na in patients with acute respiratory failure associated with community-acquired pneumonia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P | Placebo comparator | Drug: ONO-5046Na |
| E | Experimental | Drug: ONO-5046Na |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with community-acquired pneumonia
- Patients with acute respiratory failure
Key exclusion criteria (2 listed)
- Patients with nosocomial pneumonia
- Patients on mechanical ventilation
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 |
|---|---|---|
| ONO-5046Natwenty four hour infusion at 0 mg/kg/hr for 14 days | Drug | P |
| ONO-5046Natwenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days | Drug | E |
Primary outcome
pulmonary function
Time frame: 14 days
2 secondary outcomes
mortality
Time frame: 28 days
ventilator status
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 13 Jun 2012.
Related trials for Community-acquired Pneumonia
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
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.
Koji Takehara 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 2 study testing ONO-5046Na in people with Community-acquired Pneumonia, 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 2 inclusion and 2 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 13 Jun 2012. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
pulmonary function (time frame: 14 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 13 Jun 2012.