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Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation (Study P05876)

Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00903721
Enrollment
3806
Registered
2009-05-18
Start date
2008-11-30
Completion date
2012-10-31
Last updated
2022-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Brief 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. The results will be submitted to public health officials as required by applicable national and international laws.

Interventions

DRUGmometasone furoate

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

Sponsors

Organon and Co
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients who are treated with Nasonex for perennial or seasonal allergic rhinitis.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Estimate the incidence of Adverse Drug Reactions (ADRs)After 6 months of observation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026