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

Perennial Allergic Rhinitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900054
• Other study ID #: TAU-284-18
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2013
• Last updated: November 10, 2015
• Start date: June 2013
• Est. completion date: November 2013

Study information

• Verified date: September 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Bepotastine besilate
Two TAU-284 5mg tablets will be taken orally twice a day

Locations

Country	Name	City	State
Japan	Reserch site	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Adverse Events and Adverse Drug Reactions		Up to Week 12	Yes
Secondary	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.	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).	Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point (up to Week 12)	No
Secondary	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	No
Secondary	Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)		Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12	No
Secondary	Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis		baseline, Week2, Week4, Week6, Week8, Week10 and Week 12	No
Secondary	Influence of Activities in Daily Life(Study, Outing, Sleeping)		Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12	No
Secondary	Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)		Week 12 or suspension	No