Conditions: Perennial Allergic Rhinitis
Keywords: TAU-284 Bepotastine besilate Histamine H1 receptor antagonists children
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 473
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 safety of TAU-284.

Detailed description:
This is a randomized, double-blind, placebo-controlled, 2-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (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 safety of TAU-284.

Arms:
arm 1: Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed). arm 2: Two placebo tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).

Interventions: intervention 1: Bepotastine besilate intervention 2: Placebo
Intervention descriptions: intervention 1: Two TAU-284 5mg tablets will be taken orally twice a day intervention 2: Two Placebo tablets will be taken orally twice a day

Protocol document: