Allergic RhinitisNCT00903721
Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation (Study P05876)
An observational study of Allergic Rhinitis, run by Organon and Co.
Trial summary
The investigation will be conducted to define safety and efficacy under the conditions of post-marketing use of this drug in subjects with allergic rhinitis. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- mometasone furoate
- How many people
- 3,806 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Oct 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Japanese patients with perennial allergic rhinitis and/or seasonal allergic rhinitis
Who may be able to join
- Patients who are treated with Nasonex for perennial or seasonal allergic rhinitis.
Who cannot join
- Patients with an infection for which there is no effective antimicrobial drug or systemic fungal infection [symptoms may exacerbate]
- Patients with a history of hypersensitivity to any ingredient of this drug
About this study
Official title: Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation
The investigation will be conducted to define safety and efficacy under the conditions of post-marketing use of this drug in subjects with allergic rhinitis.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
- Conditions
- Allergic Rhinitis
- Being tested
- mometasone furoate
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mometasone furoateDrug
Also called Nasonex® Nasal Suspension, Nasonex
Metered-dose spray type suspension containing 50 μg mometasone furoate per spray. 2 sprays per nostril twice daily (total daily dose 200 μg)
Duration: up to 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with perennial allergic rhinitis Receives: Drug: mometasone furoate | |
| 2 | Patients with seasonal allergic rhinitis (including patients who also have perennial allergic rhinitis) Receives: Drug: mometasone furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the incidence of Adverse Drug Reactions (ADRs)
Measured: After 6 months of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startNov 2008
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,806 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903721
- Sponsor's protocol ID
- P05876
- Status last verified
- Feb 2022
- First submitted
- 14 May 2009
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation
- ClinicalTrials.gov ID
- NCT00903721
- Acronym / sponsor ID
- P05876
- Conditions
- Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,806 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 May 2009 (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 investigation will be conducted to define safety and efficacy under the conditions of post-marketing use of this drug in subjects with allergic rhinitis.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: mometasone furoatePatients with perennial allergic rhinitis |
| 2 | – | Drug: mometasone furoatePatients with seasonal allergic rhinitis (including patients who also have perennial allergic rhinitis) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese patients with perennial allergic rhinitis and/or seasonal allergic rhinitis
Key inclusion criteria (1 listed)
- Patients who are treated with Nasonex for perennial or seasonal allergic rhinitis.
Key exclusion criteria (2 listed)
- Patients with an infection for which there is no effective antimicrobial drug or systemic fungal infection [symptoms may exacerbate]
- Patients with a history of hypersensitivity to any ingredient of this drug
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 |
|---|---|---|
| mometasone furoateAlso: Nasonex® Nasal Suspension, NasonexMetered-dose spray type suspension containing 50 μg mometasone furoate per spray. 2 sprays per nostril twice daily (total daily dose 200 μg) Duration: up to 6 months | Drug | 1, 2 |
Primary outcome
Estimate the incidence of Adverse Drug Reactions (ADRs)
Time frame: After 6 months of observation
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 16 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by Organon and Co.
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 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Estimate the incidence of Adverse Drug Reactions (ADRs) (time frame: After 6 months of observation). 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 16 Feb 2022.