Status:
COMPLETED
A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)
Lead Sponsor:
Organon and Co
Conditions:
Rhinitis, Allergic, Perennial
Eligibility:
All Genders
3-15 years
Phase:
PHASE3
Brief Summary
Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric sub...
Eligibility Criteria
Inclusion
- Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree.
- Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen).
- Male or female outpatients aged 3 to 15 years at the time of providing informed consent.
Exclusion
- Subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require treatment at the time of registration
- Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
- Subjects with repeated epistaxis
- Subjects with coexisting fungal infection in nasal/sinus cavity
- Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray
- Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor.
- Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01165424
Start Date
April 1 2010
End Date
December 1 2010
Last Update
May 24 2024
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