Conditions: Seasonal Allergic Rhinitis
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 220
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2. arm 2: Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.

Interventions: intervention 1: Montelukast intervention 2: Placebo
Intervention descriptions: intervention 1: Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days intervention 2: Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days

Protocol document: