Chronic SinusitisPhase 3NCT00410735
Study of ONO-1078 in Patients With Chronic Sinusitis
A Phase 3 study testing Pranlukast hydrate in people with Chronic Sinusitis, run by Ono Pharmaceutical Co., Ltd. at 6 sites in Japan.
Trial summary
To determine the efficacy and safety of ONO-1078 in patients with chronic sinusitis in a double-blind, randomized, placebo-controlled, parallel group, multi-center study Read more about this study
- Who is it for?
- Ages 15 to 74 years
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Pranlukast hydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 495 participants
- Where
- 6 sitesJapan
- Study dates
- Dec 2006to Jun 2008
- Phase
- Phase 3
- 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 15 to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- chronic sinusitis
Who cannot join
- acute sinusitis
- chronic sinusitis with acute exacerbation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Chubu region
Chūbu
Hokuriku region
Hokuriku
Kanto region
Kanto
Kinki region
Kinki
Kyushu region
Kyushu
Tohoku region
Tōhoku
About this study
Official title: Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study
To determine the efficacy and safety of ONO-1078 in patients with chronic sinusitis in a double-blind, randomized, placebo-controlled, parallel group, multi-center study
- Conditions
- Chronic Sinusitis
- Being tested
- Placebo, Pranlukast hydrate
- Keywords
- ONO-1078, chronic sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
0 mg BID for 12 weeks
Pranlukast hydrateDrug
225 mg BID for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| P | Placebo comparator | Not described Receives: Drug: Placebo |
| E | Experimental | Not described Receives: Drug: Pranlukast hydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasal congestion
Measured: 12 weeks
rhinorrhea
Measured: 12 weeks
postnasal drip
Measured: 12 weeks
Secondary outcomes (3)
easiness of blowing nose
Measured: 12 weeks
easiness of removing postnasal drip
Measured: 12 weeks
dull headache
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hajime Yamamotoya, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410735
- Sponsor's protocol ID
- ONO-1078-37
- Status last verified
- Jun 2012
- First submitted
- 12 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
- Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study
- ClinicalTrials.gov ID
- NCT00410735
- Acronym / sponsor ID
- ONO-1078-37
- Conditions
- Chronic Sinusitis
- Keywords
- ONO-1078, chronic sinusitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jun 2008 (actual)
- First posted
- 13 Dec 2006 (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.
To determine the efficacy and safety of ONO-1078 in patients with chronic sinusitis in a double-blind, randomized, placebo-controlled, parallel group, multi-center study
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: Placebo |
| E | Experimental | Drug: Pranlukast hydrate |
Who may qualify
- Ages
- 15 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- chronic sinusitis
Key exclusion criteria (2 listed)
- acute sinusitis
- chronic sinusitis with acute exacerbation
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 |
|---|---|---|
| Placebo0 mg BID for 12 weeks | Drug | P |
| Pranlukast hydrate225 mg BID for 12 weeks | Drug | E |
Primary outcome
nasal congestion
Time frame: 12 weeks
rhinorrhea
Time frame: 12 weeks
postnasal drip
Time frame: 12 weeks
3 secondary outcomes
easiness of blowing nose
Time frame: 12 weeks
easiness of removing postnasal drip
Time frame: 12 weeks
dull headache
Time frame: 12 weeks
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.
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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.
Hajime Yamamotoya study director
Ono Pharmaceutical Co., Ltd.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pranlukast hydrate in people with Chronic Sinusitis, run by Ono Pharmaceutical Co., Ltd. at 6 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 1 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 6 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
nasal congestion (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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.