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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Perennial Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TAU-284 Low

Group Type EXPERIMENTAL

TAU-284

Intervention Type DRUG

TAU-284 Low

TAU-284 High

Group Type EXPERIMENTAL

TAU-284

Intervention Type DRUG

TAU-284 High

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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TAU-284

TAU-284 Low

Intervention Type DRUG

TAU-284

TAU-284 High

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No