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

Phase 3

Completed

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

• Registration Number: NCT01900054
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-16
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-09
• Results First Submitted: 2015-09-17
• Results First Submitted QC: 2015-11-10
• Results First Posted: 2015-12-14
• Last Update Submitted: 2016-03-10
• Last Update Posted: 2016-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

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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 with current or previous history of drug allergy
• Patients who concurrently have renal function abnormalities that may cause safety problems etc.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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).

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events and Adverse Drug Reactions	Up to Week 12

Secondary Outcome Measures

Name	Time	Method
Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)	Week 12 or suspension
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.	Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）	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).
Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)	baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)	Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis	baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Influence of Activities in Daily Life(Study, Outing, Sleeping)	Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12

Trial Locations

Locations (1)

Reserch site; 🇯🇵 Kanagawa, Japan