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

NCT01425632 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2026-01-07

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 the dose response, safety, and plasma concentrations of TAU-284.

Conditions

  • Perennial Allergic Rhinitis

Interventions

DRUG

TAU-284

TAU-284 Low

DRUG

TAU-284

TAU-284 High

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Kimihiro Okubo, M.D. Ph.D. · Department of Otorhinolaryngology, 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
2011-08-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Japan

Study Locations

More Related Trials

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 NCT01425632 on ClinicalTrials.gov