Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)

A Phase III, Double-Blind, Randomized, Placebo-Controlled Cross-over Clinical Trial to Study the Efficacy and Safety of MK-0476 in Japanese Pediatric Subjects With Seasonal Allergic Rhinitis

This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that montelukast is superior to placebo in the treatment of nasal symptoms in SAR.

Inclusion Criteria:

• Weight: ≥ 25 kg
• Height: ≥ 125 cm
• Able to record symptoms in a diary
• Has had allergic rhinitis symptoms [Japanese Cedar (JC) pollinosis]
• Tested positive for JC pollen specific immunoglobulin E (IgE) antibody assay

Exclusion Criteria:

• Has nasal findings that would interfere with evaluating nasal congestion symptoms
• Past or present medical history of bronchial asthma
• Medical history of allergies except allergic rhinitis and has possibility of dramatically worsening of these symptoms induced by JC pollen exposure