Trial | NCT01425632  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Intervention/Treatment

    bepotastine ...

  • Study Participants

    490
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.
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.
Study Started
Aug 31
2011
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2011
Results Posted
Dec 14
2015
Estimate
Last Update
Dec 14
2015
Estimate

Drug TAU-284

TAU-284 Low

Drug TAU-284

TAU-284 High

Drug Placebo

Placebo

TAU-284 Low Experimental

TAU-284 High Experimental

Placebo Placebo Comparator

Criteria 

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

Summary

TAU-284 Low

TAU-284 High

Placebo

All Events

Event Type Organ System Event Term TAU-284 Low TAU-284 High Placebo

Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)

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) .

TAU-284 Low

-0.84
units on a scale (Least Squares Mean)
Standard Error: 0.12

TAU-284 High

-0.92
units on a scale (Least Squares Mean)
Standard Error: 0.12

Placebo

-0.7
units on a scale (Least Squares Mean)
Standard Error: 0.12

Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]

Outcome Measure Data Not Reported

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

Outcome Measure Data Not Reported

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

Outcome Measure Data Not Reported

Change From Baseline in Severity Score

Outcome Measure Data Not Reported

Adverse Events and Adverse Drug Reactions

Outcome Measure Data Not Reported

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)

Outcome Measure Data Not Reported

Total

490
Participants

Age, Continuous

11.2
years (Mean)
Standard Deviation: 2.4

Sex: Female, Male

Overall Study

TAU-284 Low

TAU-284 High

Placebo

Drop/Withdrawal Reasons

TAU-284 Low

TAU-284 High

Placebo