NCT01861522

The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (A Randomized, Double-blind, Placebo-controlled Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 473 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 7 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Bepotastine besilate	Two TAU-284 5mg tablets will be taken orally twice a day
DRUG	Placebo	Two Placebo tablets will be taken orally twice a day

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-05-23
• Last updated: 2026-01-08
• Results posted: 2015-12-15

Locations

2 sites across 1 country: Japan