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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepotastine besilate | Drug | Two TAU-284 5mg tablets will be taken orally twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events and Adverse Drug Reactions | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12） |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KIMIHIRO OKUBO | Nippon Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reserch site | Kanagawa | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26364765 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TAU-284 | TAU-284 10mg twice daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAU-284 | TAU-284 10mg twice daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Adverse Events and Adverse Drug Reactions | Posted | Number | participants | Up to Week 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAU-284 | TAU-284 10mg twice daily for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C511534 | bepotastine besilate |
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| 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 |
| Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing) | Week 12 or suspension |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | 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). | Posted | Median | Standard Deviation | units on a scale | Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12） |
|
|
|
| Secondary | Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) | Not Posted | baseline, Week2, Week4, Week6, Week8, Week10 and Week 12 | Participants |
| Secondary | Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) | Not Posted | Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 | Participants |
| Secondary | Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis | Not Posted | baseline, Week2, Week4, Week6, Week8, Week10 and Week 12 | Participants |
| Secondary | Influence of Activities in Daily Life(Study, Outing, Sleeping) | Not Posted | Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 | Participants |
| Secondary | Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing) | Not Posted | Week 12 or suspension | Participants |
| 0 |
| 58 |
| 31 |
| 58 |
| Otitis externa | Infections and infestations | MedDRA 16.1 |
|
| Pharyngitis | Infections and infestations | MedDRA 16.1 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
|
| Liver function test abnormal | Investigations | MedDRA 16.1 |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Week 8 |
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| Week 10 |
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| Week 12 |
|
| final evaluation point |
|