Completed

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

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What is being tested

TAU-284

+ Placebo

Drug
Who is being recruted

Hypersensitivity+7

+ Hypersensitivity, Immediate

+ Immune System Diseases

From 7 to 15 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: August 2011
See protocol details

Summary

Principal SponsorTanabe Pharma Corporation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2011

Actual date on which the first participant was enrolled.

This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/day or 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 the dose response, safety, and plasma concentrations of TAU-284.

Official TitleA Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (A Randomized, Double-blind, Placebo-controlled Study)
NCT01425632
Principal SponsorTanabe Pharma Corporation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

490 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 7 to 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HypersensitivityHypersensitivity, ImmediateImmune System DiseasesNose DiseasesOtorhinolaryngologic DiseasesRespiratory HypersensitivityRespiratory Tract DiseasesRhinitisRhinitis, Allergic, PerennialRhinitis, Allergic

Criteria

4 inclusion criteria required to participate
Patients aged between 7 and 15 years
Patients with a weight of at least 20 kg
Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period
7 exclusion criteria prevent from participating
Patients with vasomotor rhinitis or eosinophilic rhinitis
Patients who have concurrent nasal disease that may affect the efficacy of TAU-284
Patients with a history of any of the nasal surgical procedures
Patients who have a positive result for pollen antigens which are dispersed during the study period
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Reserch site

Chūbu, JapanOpen Reserch site in Google Maps
Suspended

Reserch site

Hokuriku, Japan
Suspended

Reserch site

Kanto, Japan
Suspended

Reserch site

Kinki, Japan
Completed5 Study Centers