Conditions: Perennial Allergic Rhinitis
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 87
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The primary hypothesis of this study is that montelukast oral granules (OG) and chewable tablets (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with PAR.

Detailed description:

Arms:
arm 1: Participants receive montelukast 4 mg OG in one sachet orally (PO) once daily (QD) at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total) arm 2: Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks arm 3: Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks

Interventions: intervention 1: Montelukast Oral Granules (OG) intervention 2: Montelukast Chewable Tablets (CT)
Intervention descriptions: intervention 1: Montelukast 4 mg in one sachet intervention 2: Montelukast 5 mg in one tablet

Protocol document: