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A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A 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)

NCT01425632•Tanabe Pharma Corporation

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

7 - 15 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
•Patients who have a positive result for dog dander or cat dander antigen
•Patients with current or previous history of drug allergy
•Patients who concurrently have renal function abnormalities that may cause safety problems

Locations (5)

Reserch site

Chūbu, Japan

Reserch site

Hokuriku, Japan

Reserch site

Kanto, Japan

Reserch site

Kinki, Japan

Reserch site

Kyusyu, Japan

Key Dates

Start Date

August 1, 2011

Primary Completion Date

December 1, 2011

Completion Date

December 1, 2011

Last Updated

January 7, 2026

Enrollment

490

ACTUAL participants

Conditions

Perennial Allergic Rhinitis

Interventions

TAU-284

DRUG

TAU-284

DRUG

Placebo

DRUG

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Allergic RhinoconjunctivitisPerennial Allergic Rhinitis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

To Evaluate the Efficacy and Safety of HL151 Versus Placebo in Perennial Allergic Rhinitis Patients

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