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

Perennial Allergic Rhinitis Clinical Trial

Official title:

A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis (A Randomized, Double-blind, Placebo-controlled Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861522
• Other study ID #: TAU-284-20
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2013
• Last updated: November 10, 2015
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: November 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: December 2013
• Est. primary completion date: December 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 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), 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
• Placebo
Two Placebo tablets will be taken orally twice a day

Locations

Country	Name	City	State
Japan	Reserch site	Fukuoka
Japan	Reserch site	Toyama

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	Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]	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).	Baseline and Week 2	No
Secondary	Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]		baseline, Week1 and Week 2	No
Secondary	Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)		baseline, Week1 and Week 2	No
Secondary	Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)		baseline, Week1 and Week 2	No
Secondary	Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis		Randomization, Week1 and Week 2	No
Secondary	Adverse Events and Adverse Drug Reactions		Week 2	Yes