Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis

• Conditions: perennial allergic rhinitis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004921-41-Outside-EU/EEA
• Lead Sponsor: Corporation Schering-Plough K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-24
• Last Update Posted: 7 September 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 333

Inclusion Criteria

(1) Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, according to the classification of severity in the Practical Guideline for the Management of Allergic Rhinitis in Japan (partial revision, 2009) as well as a total score of at least 4 for nasal symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), after the pretreatment observation period. As a rule, subjects should fulfill above criteria at the time of obtaining informed consent.
(2) Subjects confirmed to be allergic to non-seasonal environmental antigens based on the tests.
(3) Male or female outpatients aged 5 to 15 years at the time of providing informed consent.
(4) Subjects whose parents/legal representatives can provide written informed consent.
(5) Subjects who can make entries in the nasal allergy diary or have a parent/legal representative who can make entries.

Are the trial subjects under 18? yes
Number of subjects for this age range: 333
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

Exclusion Criteria

(1) Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, 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 who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed
(5) Subjects with a history of hypersensitivity to steroids and other components of the study drug
(6) Female subjects with positive pregnancy test (conducted only in subjects 7 years of age and older)
(7) Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor
(8) Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the study period (at any time from the start of the observation
period to the end of treatment).
(9) Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis.
(10) Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.
(11) Subjects who develop a disease affecting nasal symptoms (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis) in the 7 days before registration in the study.
(12) Subjects who have previously received MFNS.
(13) Subjects who have taken of an investigational drug within 120 days (4 months) before the day of informed consent.
(14) Subjects for whom the period of discontinuation of previous treatment before the start of study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified