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

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ClinicalTrials.gov Identifier: NCT00903721
Recruitment Status : Completed
First Posted : May 18, 2009
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.


Condition or disease Intervention/treatment
Allergic Rhinitis Drug: mometasone furoate

Study Type : Observational
Actual Enrollment : 3806 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation
Study Start Date : November 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1
Patients with perennial allergic rhinitis
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

Other Names:
  • Nasonex® Nasal Suspension
  • Nasonex
2
Patients with seasonal allergic rhinitis (including patients who also have perennial allergic rhinitis)
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

Other Names:
  • Nasonex® Nasal Suspension
  • Nasonex



Primary Outcome Measures :
  1. Estimate the incidence of Adverse Drug Reactions (ADRs) [ Time Frame: After 6 months of observation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japanese patients with perennial allergic rhinitis and/or seasonal allergic rhinitis
Criteria

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00903721     History of Changes
Other Study ID Numbers: P05876
First Posted: May 18, 2009    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents