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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This is a randomized, double-blind, placebo-controlled, 2-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (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 safety of TAU-284.

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

Conditions
-----------------
Perennial Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Bepotastine besilate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged between 7 and 15 years Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria Patients with a mean rhinorrhea score and a mean sneezing score of at least 2 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc. 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 and have a chance to touch dogs or cats. Patients with current or previous history of drug allergy Patients who concurrently have renal function abnormalities that may cause safety problems etc.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU-284<br>Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed). | Drug: Bepotastine besilate<br>* Two TAU-284 5mg tablets will be taken orally twice a day<br>* Other names: TALION 5mg tablets;|
| Placebo Comparator: Placebo<br>Two placebo tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed). | Drug: Placebo<br>* Two Placebo tablets will be taken orally twice a day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptoms) to 4 (very severe). | Baseline and Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] |  | baseline, Week1 and Week 2 | 
| Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) |  | baseline, Week1 and Week 2 | 
| Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) |  | baseline, Week1 and Week 2 | 
| Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis |  | Randomization, Week1 and Week 2 | 
| Adverse Events and Adverse Drug Reactions |  | Week 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAU-284, Bepotastine besilate, Histamine H1 receptor antagonists, children