Conditions: Perennial Allergic Rhinitis
Keywords: TAU-284 Bepotastine besilate Histamine H1 receptor antagonists
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 490
Healthy volunteers: no

Brief summary:
The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis, and to investigate the dose response, safety, and plasma concentrations of TAU-284.

Detailed description:
This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/day or 20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with "the change from baseline in total nasal symptom score (total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\])" as the primary endpoint; and to investigate the dose response, safety, and plasma concentrations of TAU-284.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: TAU-284 intervention 2: TAU-284 intervention 3: Placebo
Intervention descriptions: intervention 1: TAU-284 Low intervention 2: TAU-284 High intervention 3: Placebo

Protocol document: