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

NCT ID: NCT01861522

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 473 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-12-31

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.

Conditions

Perennial Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TAU-284

Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).

Group Type: EXPERIMENTAL

Bepotastine besilate

Intervention Type: DRUG

Two TAU-284 5mg tablets will be taken orally twice a day

Placebo

Two placebo tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Two Placebo tablets will be taken orally twice a day

Interventions

Bepotastine besilate

Two TAU-284 5mg tablets will be taken orally twice a day

Intervention Type: DRUG

Placebo

Two Placebo tablets will be taken orally twice a day

Intervention Type: DRUG

Other Intervention Names

TALION 5mg tablets

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 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

KIMIHIRO OKUBO

Role: STUDY_DIRECTOR

Nippon Medical School

Locations

Reserch site

Fukuoka, , Japan

Reserch site

Toyama, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 26364765 (View on PubMed)

Other Identifiers

TAU-284-20

Identifier Type: -

Identifier Source: org_study_id