Clinical trial NCT01900054: A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Keywords: TAU-284
Bepotastine besilate
Histamine H1 receptor antagonists
children
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2013-07-16
Enrollment: 58
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Number of Patients With Adverse Events and Adverse Drug Reactions
timeFrame: Up to Week 12
Secondary outcomes:
measure: 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.
timeFrame: Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）
measure: Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
timeFrame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
measure: Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
timeFrame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
measure: Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
timeFrame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
measure: Influence of Activities in Daily Life(Study, Outing, Sleeping)
timeFrame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
measure: Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)
timeFrame: Week 12 or suspension
Other outcomes:
Locations:
city: Kanagawa
country: Japan
facility: Reserch site
Study officials:
affiliation: Nippon Medical School
name: KIMIHIRO OKUBO
role: STUDY_DIRECTOR
References:
citation: Okubo K, Ichimura M, Koyama T, Susuta Y, Izaki H. Double-blind placebo-controlled study of bepotastine besilate in pediatric patients with perennial allergic rhinitis. Expert Opin Pharmacother. 2015;16(16):2395-408. doi: 10.1517/14656566.2015.1085511. Epub 2015 Sep 12.