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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00903721
First received: May 14, 2009
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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 Intervention
Allergic Rhinitis
Drug: mometasone furoate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Estimate the incidence of Adverse Drug Reactions (ADRs) [ Time Frame: After 6 months of observation ] [ Designated as safety issue: Yes ]

Enrollment: 3806
Study Start Date: November 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00903721     History of Changes
Other Study ID Numbers: P05876
Study First Received: May 14, 2009
Last Updated: September 4, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone furoate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014