Conditions: Perennial Allergic Rhinitis
Keywords: TAU-284 Bepotastine besilate Histamine H1 receptor antagonists children
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 58
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

Detailed description:
This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

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).

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

Protocol document: