Seasonal Allergic RhinitisPhase 2NCT01748344
Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis
A Phase 2 study testing Cetirizine, High dose ONO-4053 and Low dose ONO-4053 in people with Seasonal Allergic Rhinitis, run by Ono Pharmaceutical Co., Ltd. at 1 site in Austria.
Trial summary
The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Cetirizine, High dose ONO-4053 and Low dose ONO-4053
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2012to Feb 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is aged between 18 and 65 years inclusive, and healthy with the exception of allergic rhinitis or mild asthma that does not require treatment and has provided written informed consent, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form.
- The subject exhibits a moderate to severe response to grass pollen grains in the allergen challenge chamber at Screening.
Who cannot join
- The subject on examination is found to have nasal structural abnormalities or nasal polyps; a history of frequent nose bleeds, nasal biopsy, nasal trauma or nasal surgery.
- Pregnant or breast-feeding females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo Controlled, Four Period Crossover Study to Evaluate the Efficacy, Safety of Oral Repeat Doses of ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis in the Vienna Challenge Chamber.
The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled conditions.
Read the detailed description
The purpose of this study is to investigate if ONO-4053 will impact allergic rhinitis symptoms in subjects with seasonal allergic rhinitis when they are exposed to pollen administered at a fixed rate in an inhalation exposure chamber compared to the standard treatment Cetirizine 10mg under the same conditions.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Cetirizine, High dose ONO-4053, Low dose ONO-4053, Placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetirizineDrug
10mg tablets
High dose ONO-4053Drug
Also called Experimental 1
Experimental
Low dose ONO-4053Drug
Also called Experimental 2
Experimental
PlaceboDrug
None active
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | High dose ONO-4053 Receives: Drug: High dose ONO-4053 |
| Cetirizine | Active comparator | 10mg Cetirizine Receives: Drug: Cetirizine |
| Experimental 2 | Experimental | Low dose ONO-4053 Receives: Drug: Low dose ONO-4053 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score
To investigate the effect of repeat oral doses of ONO-4053 versus placebo on nasal symptoms elicited by allergen chamber challenge in subjects with seasonal allergic rhinitis.
Measured: 4 months
Secondary outcomes (3)
Total Nasal Symptom Score
To investigate the effect of repeat oral doses of ONO-4053 versus Cetirizine on nasal symptoms (Total Nasal Symptom Score) elicited by allergen chamber challenge in subjects with allergic rhinitis.
Measured: 4 months
Total Ocular Symptom Score
Itching and ocular discharge monitored daily
Measured: 4 months
Pharmacokinetics
AUE (0-2h, 2-6h and 0-6h)
Measured: Days 1 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748344
- Sponsor's protocol ID
- ONO-4053POE003
- Status last verified
- Sep 2012
- First submitted
- 1 Nov 2012
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo Controlled, Four Period Crossover Study to Evaluate the Efficacy, Safety of Oral Repeat Doses of ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis in the Vienna Challenge Chamber.
- ClinicalTrials.gov ID
- NCT01748344
- Acronym / sponsor ID
- ONO-4053POE003
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2014 (actual)
- First posted
- 12 Dec 2012 (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 investigate if ONO-4053 relieves symptoms of allergic rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled conditions.
Detailed description
The purpose of this study is to investigate if ONO-4053 will impact allergic rhinitis symptoms in subjects with seasonal allergic rhinitis when they are exposed to pollen administered at a fixed rate in an inhalation exposure chamber compared to the standard treatment Cetirizine 10mg under the same conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: High dose ONO-4053High dose ONO-4053 |
| Cetirizine | Active comparator | Drug: Cetirizine10mg Cetirizine |
| Experimental 2 | Experimental | Drug: Low dose ONO-4053Low dose ONO-4053 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subject is aged between 18 and 65 years inclusive, and healthy with the exception of allergic rhinitis or mild asthma that does not require treatment and has provided written informed consent, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form.
- The subject exhibits a moderate to severe response to grass pollen grains in the allergen challenge chamber at Screening.
Key exclusion criteria (2 listed)
- The subject on examination is found to have nasal structural abnormalities or nasal polyps; a history of frequent nose bleeds, nasal biopsy, nasal trauma or nasal surgery.
- Pregnant or breast-feeding females.
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 |
|---|---|---|
| Cetirizine10mg tablets | Drug | Cetirizine |
| High dose ONO-4053Also: Experimental 1Experimental | Drug | Experimental 1 |
| Low dose ONO-4053Also: Experimental 2Experimental | Drug | Experimental 2 |
| PlaceboNone active | Drug | Placebo |
Primary outcome
Total Nasal Symptom Score
Time frame: 4 months
To investigate the effect of repeat oral doses of ONO-4053 versus placebo on nasal symptoms elicited by allergen chamber challenge in subjects with seasonal allergic rhinitis.
3 secondary outcomes
Total Nasal Symptom Score
Time frame: 4 months
Total Ocular Symptom Score
Time frame: 4 months
Pharmacokinetics
Time frame: Days 1 and 8
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 15 Apr 2014.
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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.
Study Director study director
Ono Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetirizine, High dose ONO-4053 and Low dose ONO-4053 in people with Seasonal Allergic Rhinitis, run by Ono Pharmaceutical Co., Ltd. at 1 site in Austria.
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 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Total Nasal Symptom Score (time frame: 4 months). 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 15 Apr 2014.