Perennial Allergic RhinitisPhase 3NCT01861522
The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
A Phase 3 study testing Bepotastine besilate in people with Perennial Allergic Rhinitis, run by Tanabe Pharma Corporation at 2 sites in Japan.
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 safety 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?
- Bepotastine besilate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 473 participants
- Where
- 2 sitesJapan
- Study dates
- Apr 2013to Dec 2013
- 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 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.
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 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.
Trial locations and contacts
2 sites in 1 country.
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)
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.
Read the 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
- Being tested
- Bepotastine besilate, Placebo
- Keywords
- TAU-284, Bepotastine besilate, Histamine H1 receptor antagonists, children
- 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.
Bepotastine besilateDrug
Also called TALION 5mg tablets
Two TAU-284 5mg tablets will be taken orally twice a day
PlaceboDrug
Two Placebo tablets will be taken orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). 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]
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).
Measured: Baseline and Week 2
Secondary outcomes (5)
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
Measured: baseline, Week1 and Week 2
Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
Measured: baseline, Week1 and Week 2
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Measured: baseline, Week1 and Week 2
Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
Measured: Randomization, Week1 and Week 2
Adverse Events and Adverse Drug Reactions
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KIMIHIRO OKUBO, Study director, Nippon Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861522
- Sponsor's protocol ID
- TAU-284-20
- Status last verified
- Dec 2025
- First submitted
- 19 May 2013
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26364765