A study of long-term (12-24 weeks) administration of mometasone furoate nasal spray in pediatric subjects with perennial allergic rhinitis (Protocol No. P06333) - A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects

Corporation Schering-Plough K.K.0 sites80 target enrollmentFebruary 24, 2015

Overview

No summary available.

Registry

who.int

Start Date

February 24, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Corporation Schering-Plough K.K.

•1\. Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree.
•2\. Subjects confirmed to be allergic to non\-seasonal environmental antigens (e.g., house dust mite antigen).
•3\. Male or female outpatients aged 3 to 15 years at the time of providing informed consent.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 80
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•1\. 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
•2\. Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
•3\. Subjects with repeated epistaxis
•4\. Subjects with coexisting fungal infection in nasal/sinus cavity
•5\. Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray
•6\. Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor.
•7\. Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period