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

NCT01861522 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 473

Last updated 2026-01-08

Study results available
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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.

Conditions

  • Perennial Allergic Rhinitis

Interventions

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

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • KIMIHIRO OKUBO · Nippon Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Japan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01861522 on ClinicalTrials.gov