Perennial Allergic RhinitisPhase 3NCT01425632

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

A Phase 3 study testing TAU-284 in people with Perennial Allergic Rhinitis, run by Tanabe Pharma Corporation at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 the dose response, safety, and plasma concentrations of TAU-284. Read more about this study

Who is it for?: Ages 7 to 15 years
Conditions the study is for: Perennial Allergic Rhinitis
What is being tested?: TAU-284
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 490 participants
Where: 5 sitesJapan
Study dates: Aug 2011to Dec 2011
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

Reserch site
Chūbu
Reserch site
Hokuriku
Reserch site
Kanto
Reserch site
Kinki
Reserch site
Kyusyu

Other trials in Japan

About this study

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

Read the detailed description

This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/day or 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 the dose response, safety, and plasma concentrations of TAU-284.

Conditions: Perennial Allergic Rhinitis
Being tested: TAU-284, Placebo
Keywords: TAU-284, Bepotastine besilate, Histamine H1 receptor antagonists
Medical subject headings: Rhinitis, Allergic, Perennial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAU-284Drug
TAU-284 Low
TAU-284Drug
TAU-284 High
PlaceboDrug
Placebo

Study groups in NCT01425632
Study group	Role	What they receive
TAU-284 Low	Experimental	Not described Receives: Drug: TAU-284
TAU-284 High	Experimental	Not described Receives: Drug: TAU-284
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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) .
Measured: Baseline and Week 2

Secondary outcomes (6)

Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
Measured: Week 2
Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
Measured: Week 2
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Measured: Week 2
Change From Baseline in Severity Score
Measured: Week 2
Adverse Events and Adverse Drug Reactions
Measured: Week 2
Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)
Measured: Week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Dec 2011

First posted30 Aug 2011 (estimated)
Study startAug 2011
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 490 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01425632
Sponsor's protocol ID: TAU-284-17
Status last verified: Dec 2025
First submitted: 28 Aug 2011
Last updated: 7 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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