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

Phase 3CompletedNCT01900054

Tanabe Pharma Corporation58 enrolled

Overview

The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Perennial Allergic Rhinitis

Interventions

Bepotastine besilateDRUG

Two TAU-284 5mg tablets will be taken orally twice a day

Eligibility

Sex: ALLMin age: 7 YearsMax age: 15 Years

Medical Language ↔ Plain English

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 total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\] of at least 3 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 with current or previous history of drug allergy * Patients who concurrently have renal function abnormalities that may cause safety problems etc.

Locations (1)

Reserch site

Kanagawa, Japan

Outcomes

Primary Outcomes

Number of Patients With Adverse Events and Adverse Drug Reactions

Time frame: Up to Week 12

Secondary Outcomes

Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point.

Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).

Time frame: Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）

Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)

Time frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12

Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)

Time frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12

Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis

Time frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12

Influence of Activities in Daily Life(Study, Outing, Sleeping)

Time frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12

Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)

Time frame: Week 12 or suspension

Data from ClinicalTrials.gov

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