Perennial Allergic RhinitisPhase 3NCT01900054
A Long-Term 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 1 site in Japan.
Trial 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. 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?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2013to Nov 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 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.
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 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
1 site in 1 country.
About this study
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.
Read the detailed description
This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Bepotastine besilate
- 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
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events and Adverse Drug Reactions
Measured: 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.
Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).
Measured: 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)
Measured: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Measured: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
Measured: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Influence of Activities in Daily Life(Study, Outing, Sleeping)
Measured: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)
Measured: Week 12 or suspension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completionNov 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 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
- NCT01900054
- Sponsor's protocol ID
- TAU-284-18
- Status last verified
- Dec 2025
- First submitted
- 3 Jul 2013
- Last updated
- 7 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