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

Phase 3

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: Bepotastine besilate; Drug: Placebo

• Registration Number: NCT01861522
• 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 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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-19
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-23
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2015-09-17
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-10
• Last Update Submitted: 2015-11-10
• Results First Posted: 2015-12-15
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 473

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU-284	Bepotastine besilate	Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).
Placebo	Placebo	Two placebo tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]	Baseline and Week 2	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).

Secondary Outcome Measures

Name	Time	Method
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
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]	baseline, Week1 and Week 2

Trial Locations

Locations (1)

Reserch site; 🇯🇵 Toyama, Japan