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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 2011

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.

Interventions

  • Drug: TAU-284
    • TAU-284 Low
  • Drug: TAU-284
    • TAU-284 High
  • Drug: Placebo
    • Placebo

Arms, Groups and Cohorts

  • Experimental: TAU-284 Low
  • Experimental: TAU-284 High
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)
    • Time Frame: Baseline and Week 2
    • Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .

Secondary Measures

  • Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
    • Time Frame: Week 2
  • Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
    • Time Frame: Week 2
  • Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
    • Time Frame: Week 2
  • Change From Baseline in Severity Score
    • Time Frame: Week 2
  • Adverse Events and Adverse Drug Reactions
    • Time Frame: Week 2
  • Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)
    • Time Frame: Week 2

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mitsubishi Tanabe Pharma Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kimihiro Okubo, M.D. Ph.D., Study Director, Department of Otorhinolaryngology, Nippon Medical School

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