NCT01900054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 14, 2015

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

July 3, 2013

Results QC Date

September 17, 2015

Last Update Submit

December 15, 2025

Conditions

Perennial Allergic Rhinitis

Keywords

TAU-284Bepotastine besilateHistamine H1 receptor antagonistschildren

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Adverse Events and Adverse Drug Reactions

    Up to Week 12

Secondary Outcomes (6)

  • 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.

    Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）

  • 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

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

    Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12

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

    baseline, Week2, Week4, Week6, Week8, Week10 and Week 12

  • Influence of Activities in Daily Life(Study, Outing, Sleeping)

    Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

Bepotastine besilateDRUG

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

Also known as: TALION 5mg tablets
TAU-284

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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 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.

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 with current or previous history of drug allergy
  • Patients who concurrently have renal function abnormalities that may cause safety problems etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reserch site

Kanagawa, 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: 26364765RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

bepotastine besilate

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune 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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 16, 2013

Study Start

June 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 7, 2026

Results First Posted

December 14, 2015

Record last verified: 2025-12

Locations

JP(1)