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NCT00903721 Clinical Trial

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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00903721
Other study ID # P05876
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2008
Est. completion date October 2012

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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

Recruitment information / eligibility
Status Completed
Enrollment 3806
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Estimate the incidence of Adverse Drug Reactions (ADRs) After 6 months of observation
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