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

NCT00903721 | Completed

• 1 other identifier: P05876
• Study Type: observational
• Target: 3,806
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Estimate the incidence of Adverse Drug Reactions (ADRs)

  After 6 months of observation

Study Arms (2)

1

Patients with perennial allergic rhinitis

Drug: mometasone furoate

2

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

Drug: mometasone furoate

Interventions

mometasone furoate 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

Also known as: Nasonex® Nasal Suspension, Nasonex

1; 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Japanese patients with perennial allergic rhinitis and/or seasonal allergic rhinitis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 18, 2009
• Study Start: November 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 16, 2022

Record last verified: 2022-02