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

NCT ID: NCT00903721

Last Updated: 2022-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3806 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with perennial allergic rhinitis

mometasone furoate

Intervention Type DRUG

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

2

Patients with seasonal allergic rhinitis (including patients who also have perennial allergic rhinitis)

mometasone furoate

Intervention Type DRUG

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

Interventions

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mometasone 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

Intervention Type DRUG

Other Intervention Names

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Nasonex® Nasal Suspension Nasonex

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P05876

Identifier Type: -

Identifier Source: org_study_id

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