Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis Pediatric PATANASE
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 132
Healthy volunteers: no

Brief summary:
The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in these children

Detailed description:

Arms:
arm 1: Olopatadine Hydrochloride Nasal Spray 0.6% arm 2: Olopatadine Hydrochloride Nasal Spray Vehicle

Interventions: intervention 1: Olopatadine Hydrochloride Nasal Spray 0.6% intervention 2: Olopatadine Hydrochloride Nasal Spray Vehicle
Intervention descriptions: intervention 1: one spray in each nostril twice daily for 2 weeks intervention 2: one spray in each nostril twice daily for 2 weeks

Protocol document: