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

Phase 3

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: TAU-284

• Registration Number: NCT01425632
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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 the dose response, safety, and plasma concentrations of TAU-284.

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-28
• Study First Submitted QC: 2011-08-28
• Study First Posted: 2011-08-30
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2015-09
• Results First Submitted: 2015-09-17
• Results First Submitted QC: 2015-11-10
• Last Update Submitted: 2015-11-10
• Results First Posted: 2015-12-14
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
TAU-284 High	TAU-284	-
TAU-284 Low	TAU-284	-

Primary Outcome Measures

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

Name	Time	Method
Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)	Week 2
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)	Week 2
Change From Baseline in Severity Score	Week 2
Adverse Events and Adverse Drug Reactions	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)	Week 2
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]	Week 2

Trial Locations

Locations (1)

Reserch site; 🇯🇵 Kyusyu, Japan