NCT01425632

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 the dose response, safety, and plasma concentrations of TAU-284.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
490

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

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

August 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
4 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

4 months

First QC Date

August 28, 2011

Results QC Date

September 17, 2015

Last Update Submit

December 15, 2025

Conditions

Perennial Allergic Rhinitis

Keywords

TAU-284Bepotastine besilateHistamine H1 receptor antagonists

Outcome Measures

Primary Outcomes (1)

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

    Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .

    Baseline and Week 2

Secondary Outcomes (6)

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

    Week 2

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

    Week 2

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

    Week 2

  • Change From Baseline in Severity Score

    Week 2

  • Adverse Events and Adverse Drug Reactions

    Week 2

  • +1 more secondary outcomes

Study Arms (3)

TAU-284 Low

EXPERIMENTAL
Drug: TAU-284

TAU-284 High

EXPERIMENTAL
Drug: TAU-284

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TAU-284DRUG

TAU-284 Low

TAU-284 Low
PlaceboDRUG

Placebo

Placebo

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 with a weight of at least 20 kg
  • Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria
  • Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Reserch site

Chūbu, Japan

Location

Reserch site

Hokuriku, Japan

Location

Reserch site

Kanto, Japan

Location

Reserch site

Kinki, Japan

Location

Reserch site

Kyusyu, Japan

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

bepotastine

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, M.D. Ph.D.

    Department of Otorhinolaryngology, 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

August 28, 2011

First Posted

August 30, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 7, 2026

Results First Posted

December 14, 2015

Record last verified: 2025-12

Locations

JP(5)