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

NCT01861522 | Completed Phase 3 Results

• 1 other identifier: TAU-284-20
• Study Type: interventional
• Target: 473
• Locations: 1 country
• Sites: 2

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.

Conditions

Perennial Allergic Rhinitis

Keywords

TAU-284; Bepotastine besilate; Histamine H1 receptor antagonists; children

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]

  baseline, Week1 and Week 2

• Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)

  baseline, Week1 and Week 2

• Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)

  baseline, Week1 and Week 2

• Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis

  Randomization, Week1 and Week 2

• Adverse Events and Adverse Drug Reactions

  Week 2

Study Arms (2)

TAU-284

EXPERIMENTAL

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

Drug: Bepotastine besilate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Bepotastine besilate DRUG

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

Also known as: TALION 5mg tablets

TAU-284

Placebo DRUG

Two Placebo tablets will be taken orally twice a day

Placebo

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (2)

Reserch site

Fukuoka, Japan

Location

Reserch site

Toyama, Japan

Location

Related 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. Epub 2015 Sep 12.

  PMID: 26364765 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

bepotastine besilate

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• KIMIHIRO OKUBO

  Nippon Medical School

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2013
• First Posted: May 23, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 8, 2026
• Results First Posted: December 15, 2015

Record last verified: 2025-12

Locations

JP (2)